Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Carcinoma

Breast Diseases

Skin Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Ropivacaine

Anesthetics, Local

PECS 2 (or modified PECS) is a block that involves the administration of local anesthetic under ultrasound guidance between the great pectoral and small pectoral and between the small pectoral and serratus anterior.

ESP block is a block that involves injection of local anesthetic below the elevator muscles of the spine.

With the patient supine, the linear probe will be placed in the sagittal plane slightly lateral to the hemiclavicular line ipsilateral to the surgical site. Once both muscle planes of interest have been identified, in-plane needle insertion will proceed in the cranio-caudal direction. The first local anesthetic administration with Ropivacaine 0.5% will be 20ml between small pectoralis and serratus anterior. Coming out with the needle, 10ml of Ropivacaine 0.5% will then be injected between large and small pectoral.

PECS BLOCK 2

Positioning yourself behind the patient, lying on her side with the surgical hemilateral on top, you place the linear ultrasound probe in the sagittal plane and find the lateral margin of the transverse process. At this point, the blocking needle is inserted in the caudocranial direction and 25ml of Ropivacaine 0.5% is injected, taking care to visualize the anesthetic spread in the cranial direction.

ESP BLOCK

Mirco Leo, Physician

The study aims to compare the efficacy of the two operating blocks PECS2 and ESP by measuring postoperative opioid consumption and, secondarily, to compare (between PECS and ESP) postoperative opioid consumption between surgery with/without axillary cavity dissection and with/without implantation of prosthesis or expansion

Breast cancer is the most frequent type of cancer in the female population. Early detection is the most effective tool for improving prognosis, and the surgical approach plays a central role in the treatment of this disease. However, many are the psychophysical implications that patients face: among the main ones is postoperative and chronic pain, a symptom that greatly worsens the quality of life.

In the last decade it has been witnessed an important development of locoregional anesthesia techniques in all surgeries. In breast surgery, particularly mastectomy, the following locoregional anesthesia techniques are referred to as the Gold Standard:

1. PVB (Paravertebral Block)
2. PECS2 BLOCK (or modified PECS). For the same purposes, ESP Block (Erector Spinae Plane Block) has been applied experimentally, which has already shown its effectiveness in breast surgery in several trials.

By comparing postoperative opioid consumption between the two groups of patients, divided into PECS Block and ESP Block, the study aims to identify which anesthesia block is most effective in order to improve the care of patients undergoing mastectomy.

Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery

Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery: Randomized Controlled Trial on Postoperatory Oppioid Consumption

Morphine-equivalent consumption in the postoperative 24h that patients self-administer between the group of patients undergoing ESP and those undergoing PECS 2 in simple mastectomies.

Morphine-equivalent consumption in the postoperative 24h that patients self-administer between the group of patients undergoing ESP and those undergoing PECS 2 in mastectomies with axillary cavity emptying.

Consumption of morphine equivalents in the postoperative 24h that patients self-administer between the group of patients undergoing ESP and those undergoing PECS 2 in astecctomies with prosthesis or expander placement.

Consumption of morphine equivalents in the postoperative 24h that patients self-administer between the group of patients undergoing ESP and those undergoing PECS 2 in mastectomies with axillary cavity emptying and implantation of prosthesis or expander

Number of times the patient experienced nausea or vomiting

Number of times the patient experienced complications such as bleeding or pneumothorax

Patient satisfaction, from 1 - Strongly disagree to 5 - Strongly agree

Surgeon satisfaction, from 1 - Strongly disagree to 5 - Strongly agree

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Pain, Postoperative

Pain

Mastodynia

Postoperative Complications

Neurologic Manifestations

Chronic Graft Versus Host Disease

Bupivacaine

The patient is positioned in the prone position, the probe is used to locate in cross-section the T4 spinous process. Next, using a lateral scan, approximately 3 cm away, the costotransverse joint is located, and then change to sagittal ultrasound vision. By locating the intertransverse line with the probe, the following anatomical structures can be identified: three longitudinal muscles (trapezius, rhomboid, erector spinae).

The needle enters in a single punction at an angle of 45º, in the cranio-caudal direction, until it touches the apex of the costotransverse image. Subsequently, 30 cc of 0.25% bupivacaine are administered in the depth of the erector spinae, which will remain elevated.

The patient is positioned supine, with the ipsilateral upper limb extended. The clavicular external third line is drawn. In parallel, the lower costal line and the infraclavicular space are highlighted. The probe obtains an image that allows the identification of the pectoralis major and pectoralis minor.

If colour Doppler is added, the acromiothoracic artery is identified and must be avoided.

The needle enters at an angle of 45º from medial to lateral, and 20 cc of 0.25% bupivacaine are administered. Next, needle advances in the interfascial space between the pectoral minor and serratus anterior and 10 cc of 0.25% bupivacaine are administered.

The patient is positioned supine, with the ipsilateral upper extremity at a 90º angle. The fourth, fifth, and sixth intercostal spaces are identified in the mid-axillary line. In coronal section, it is possible to appreciate the subcutaneous cellular tissue, the serratus anterior, and the intercostal muscles.

The needle is introduced at an angle of 30º. From caudal to cranial and resting the needle on the fourth rib, 30 cc of 0.25% bupivacaine are administered between the serratus anterior and lateral intercostal muscles.

Interfascial blocks emerged as locoregional techniques that incorporate ultrasonography to visualise the anatomy while administrating the drug, reducing the rate of complications. There are multiple locoregional interfascial techniques continue to be implemented; in 2011 Blanco described Pectoral Nerve Block (PECS block); in 2012, Serratus-Intercostal Fascial Plane Block (SIFP) was described, and in 2016, Forero described the Erector Spinae Plane Block (ESP).

Drug: 30 cc 0.25% bupivacaine. Nerves blocked by SIFP block: lateral and anterior cutaneous branches of the 2nd-6th Intercostal Nerves.

Devices: S-Nerve® ultrasound was used in all three techniques; linear 6 to 13 Megahertz and convex 2 to 5 Megahertz transducers and 22G (Gauge) x 50 mm needles.

SIFP Block Locoregional Interfascial Anesthesic Technique

Interfascial blocks emerged as locoregional techniques that incorporate ultrasonography to visualise the anatomy while administrating the drug, reducing the rate of complications. There are multiple locoregional interfascial techniques continue to be implemented; in 2011 Blanco described Pectoral Nerve Block (PECS block); in 2012, Serratus-Intercostal Fascial Plane Block (SIFP) was described, and in 2016, Forero described the Erector Spinae Plane Block (ESP).

Drug: 30 cc 0.25% bupivacaine. Nerves blocked by PECS-II: Lateral Pectoral Nerve and Medial Pectoral Nerve Devices: S-Nerve® ultrasound was used in all three techniques; linear 6 to 13 Megahertz and convex 2 to 5 Megahertz transducers and 22G (Gauge) x 50 mm needles.

PECS II block: Locoregional Interfascial Anesthesic Technique

Interfascial blocks emerged as locoregional techniques that incorporate ultrasonography to visualise the anatomy while administrating the drug, reducing the rate of complications. There are multiple locoregional interfascial techniques continue to be implemented; in 2011 Blanco described Pectoral Nerve Block (PECS block); in 2012, Serratus-Intercostal Fascial Plane Block (SIFP) was described, and in 2016, Forero described the Erector Spinae Plane Block (ESP).

Drug: 30 cc 0.25% bupivacaine. Nerves blocked by ESP Block: dorsal and ventral branch block of the spinal nerves; white and gray communicating branches of the sympathetic nerves that go to the thoracic sympathetic chain.

Devices: S-Nerve® ultrasound was used in all three techniques; linear 6 to 13 Megahertz and convex 2 to 5 Megahertz transducers and 22G (Gauge) x 50 mm needles.

ESP block: Locoregional Interfascial Anesthesic Technique

Jose De Andrés Ibáñez, MD, PhD

The present study compares the Erector Spinae Plane (ESP) block, Pectoral (PECS II) block, and Serratus-Intercostal Fascial Plane (SIFP) block. This is the first article to compare these three locoregional nerve block techniques in acute and chronic postoperative pain in breast tumour surgery.

From June 1, 2018, to June 30, 2019, 103 patients undergoing breast cancer surgery were randomised to undergo one of three locoregional techniques (35 for ESP block, 34 for PECS II block, 34 for SIFP block). Locoregional techniques were performed under light sedation and then, general anaesthesia was used for the breast cancer surgery. Outcomes measured included pain (visual analog scale \[VAS\] in immediate postoperatory and at 24 hours. It also was collected opioid use at 24 hours, adverse events, and length of stay (for acute postoperatory). Moreover, at 3 months, a telephone interview was conducted with the patient and VAS was questioned. A year later, the patient was questioned again and asked for VAS, location of her pain, and pharmacological treatment. It was collected if patients were assisted or not by a Pain Unit.

Introduction

Breast surgery, armpit surgery, and the possible addition of reconstructive surgery lead to acute postoperative pain. Anaesthesiology aims to manage this pain adequately, with locoregional anaesthesia as a key tool in constant evolution.

In 2011, Blanco described the Pectoral Nerve Block (PECS). Interfascial blocks emerged as locoregional techniques that incorporate ultrasonography to visualise the anatomy while administrating the drug, reducing the rate of complications. Since then, multiple locoregional interfascial techniques continue to be implemented; in 2012, Serratus-Intercostal Fascial Plane Block (SIFP) was described, and in 2016, Forero described the Erector Spinae Plane Block (ESP).

However, there is little literature that compares the various blocks that exist. The investigators conducted a literature search in PubMed, Cochrane, and clinicaltrials.gov, with a study period from January 2011 to February 2021. The descriptors used were Erector Spinae Plane Block AND Breast, Pectoral Block AND Breast, Intercostal Nerve Block AND Breast, Locoregional Anaesthesia AND Breast, Serratus Anterior Plane Block AND Breast Surgery. The inclusion criteria were: studies with female patients, related to surgical intervention of breast tumour pathology, including every type of surgery, and publications in English or Spanish. The exclusion criteria were: studies of another type of locoregional anaesthesia; studies that do not separately evaluate the efficacy of the block but add more than one locoregional anaesthetic technique; studies with purely anatomical purposes (in cadaver, radiological, experimental animal model); and research on pharmacological issues. A total of 917 references were obtained, and after applying the different filters, this was reduced to 11 publications. These studies conclude that acute postoperative pain management is better when supplementing the patient with locoregional technique than without locoregional anaesthesia.

Moreover, chronic postoperative pain (CPP) in breast tumour surgery has an overall incidence of 25-30% one year after the intervention. The best established risk factor for CPP is having suffered severe and uncontrolled postoperative acute pain (PAP) as well as the existence of preoperative pain, requiring large consumption of analgesia in the perioperative period. Actually, 10-50% of postoperative patients with pain will develop CPP. An adequate approach of PAP reduces the risk of CPP.

There is literature enough to affirm that supplementing patients with locoregional technique to general anesthesia for breast tumour surgery, gets a better pain control than only undergoing general anesthesia. However, there is a lack of literature comparing the effectiveness of applying interfascial locoregional techniques, and it is unknown which one of them could be more recommended to prevent CPP.

Approval by the Ethics Committee

This controlled clinical trial was approved by the Ethics Committee for Research with Medicines of the Institut d'Investigació Sanitària Pere Virgili (IISPV) in Tarragona, Spain (Ref. 070/2018 dated May 31, 2018). The principles of the Helsinki Declaration were respected. Written informed consent was obtained from every patient.

Sample Size

The sample size was determined in the study design by the IISPV so that it was appropriate for the objectives set and assuming the particular conditions. The calculation was performed with a public software called GRANMO, version 7.12, for analysis of variances after reviewing the literature. Accepting an alpha risk of 0.05 and beta risk of less than 0.2 in bilateral contrast, 34 subjects were necessary for each of the three groups to detect a minimum difference of 2 points on the Visual Analogue Scale (VAS) and a standard deviation of 2.4. A loss to follow-up rate of 10% was considered.

Period of study

During the 13-month period (from June 1, 2018 to June 30, 2019), 165 patients underwent breast cancer surgery, of which 103 were included in the present study.

Population assigned to the health department corresponding to the Verge de la Cinta Hospital in Tortosa (Tarragona) that underwent elective surgery for breast tumor pathology.

Methodology

Hypothesis

The initial hypothesis of the study proposes that the Erector Spinae Plane Block (ESP) confers better control of acute postoperative pain and less chronic postoperative pain than the other two more common locoregional anesthesia methods (Pectoral Nerve Block type II -PECS II block- or Serratus-Intercostal Fascial Plane block -SIFP block).

Masking and Randomization

Randomisation was carried out by blocks in a 1: 1: 1 ratio, avoiding numerical inequality between the treatment groups. In this way, the patient was incorporated into block 1 (ESP), next patient to block 2 (PECS II), and the next patient to block 3 (SIFP).

The type of masking applied was:

First part of study (until 24 hours after surgery): single-blind, the patient did not know what type of treatment he had received, but the anaesthesiologist in the operating room, and the main intraoperative and immediate postoperative period evaluator were aware of all this.

Second part of study (3 months and 1 year after surgery): double-blind, the patient did not know what type os treatment he had received, and the anesthesiologist who was the responsible of collecting data through the telephone interview or her medical history, did not know the treatment taken by the patient.

The variables taken into account were:

Age Body mass index Tumour size Visual Analogue Scale (VAS) score Pathological diagnosis Tumour staging Type of surgery.

Anesthetic Procedure

All patients were monitored with pulse oximetry (SpO2), a six-lead electrocardiogram, and non-invasive blood pressure. The corresponding locoregional technique was performed under light sedation with IV midazolam 0.015-0.03 mg / kg and supplemental oxygen with nasal cannulas. S-Nerve® ultrasound was used in all three techniques; linear 6 to 13 Megahertz and convex 2 to 5 Megahertz transducers and 22G (Gauge) x 50 mm needles.

Erector Spinae Plane block (ESP block):

The patient is positioned in the prone position, the probe is used to locate in cross-section the T4 spinous process. Next, using a lateral scan, approximately 3 cm away, the costotransverse joint is located, and then change to sagittal ultrasound vision. By locating the intertransverse line with the probe, the following anatomical structures can be identified: three longitudinal muscles (trapezius, rhomboid, erector spinae).

The needle enters in a single punction at an angle of 45º, in the cranio-caudal direction, until it touches the apex of the costotransverse image. Subsequently, 30 cc of 0.25% bupivacaine are administered in the depth of the erector spinae, which will remain elevated.

Pectoral Nerve Block type II (PECS II block):

The patient is positioned supine, with the ipsilateral upper limb extended. The clavicular external third line is drawn. In parallel, the lower costal line and the infraclavicular space are highlighted. The probe obtains an image that allows the identification of the pectoralis major and pectoralis minor.

If colour Doppler is added, the acromiothoracic artery is identified and must be avoided.

The needle enters at an angle of 45º from medial to lateral, and 20 cc of 0.25% bupivacaine are administered. Next, needle advances in the interfascial space between the pectoral minor and serratus anterior and 10 cc of 0.25% bupivacaine are administered.

Serratus-Intercostal Fascial Plane Block (SIFP block):

The patient is positioned supine, with the ipsilateral upper extremity at a 90º angle. The fourth, fifth, and sixth intercostal spaces are identified in the mid-axillary line. In coronal section, it is possible to appreciate the subcutaneous cellular tissue, the serratus anterior, and the intercostal muscles.

The needle is introduced at an angle of 30º. From caudal to cranial and resting the needle on the fourth rib, 30 ml of 0.25% bupivacaine are administered between the serratus anterior and lateral intercostal muscles.

Operating room

Next, the patient entered the operating room, and the standard anaesthetic procedure was performed-monitoring with a six-lead electrocardiogram, non-invasive blood pressure, pulse oximetry, and bispectral index. General anaesthesia was induced with intravenous fentanyl 2 mcg/kg, propofol 2-3 mg/kg, and a laryngeal mask adjusted to each patient.

Anaesthetic maintenance was either balanced general anaesthesia with sevoflurane, or total intravenous anaesthesia with propofol in continuous infusion. Ventilation was controlled to maintain normocapnia.

Conventional intravenous analgesia was administered, per protocol was paracetamol 1 g and dexketoprofen 50 mg (in case of allergy to any of these drugs, metamizole 2 g would be administered instead). In addition, as prophylaxis for postoperative nausea and vomiting, ondansetron 4 mg was administered at the end of the intervention.

The anaesthesiologist responsible for the intraoperative period collected data on intraoperative hemodynamic stability, and on the drugs administered.

Postoperative

After anaesthetic delivery, the patients were transferred to the Post-Anaesthesia Recovery (PAR). In the immediate postoperative period, the PAR anaesthesiologist responsible collected the VAS reported by the patient. The postoperative analgesia regimen in PAR consisted of metamizole 2 g, and the responsible physician could prescribe an opioid dose if VAS \> 3 at any time during their stay.

After discharge from PAR, if the patient were under the Major Ambulatory Surgery program, the participants would be prescribed postoperative analgesia for 48 hours with paracetamol 1 g every 8 hours and metamizole 575 mg every 8 hours alternately.

In case of hospitalisation, the analgesia regimen consisted of paracetamol 1 g every 8 hours associated with metamizole 2 g every 6 hours. If the patient reported VAS\> 3, opioids could be administered according to the individualised care.

Data were collected for the VAS at 24 hours, and the rescue opioids (drug and dose) administered in the first 24 hours. In addition, the length of hospital stay was also collected.

3 months after surgery, the corresponding investigator will collect the VAS score from the patient through a telephonic interview.

1 year after surgery, the corresponding investigator will collect the VAS score, the analgesic treatment needed and location of chronic postoperative pain, from the patient through a telephonic interview. The researcher will collect the analgesic treatment through patient's medical history, and the possible assistance or not by a specialized Pain Unit.

Patients undergoing breast tumour surgery were randomised to undergo one of three locoregional techniques in three study groups (Erector Spinae Plane block -ESP block-, Pectoral Nerve Block type II -PECS II block-, or Serratus-Intercostal fascial Plane Block-SIFP block). Locoregional techniques were performed under light sedation and then, general anaesthesia was used for the breast tumour surgery.

The type of masking applied was:

First part of study (until 24 hours after surgery): single-blind, the patient did not know what type of treatment he had received, but the anaesthesiologist in the operating room, and the main intraoperative and immediate postoperative period evaluator were aware of all this.

Second part of study (3 months and 1 year after surgery): double-blind, the patient did not know what type os treatment he had received, and the anesthesiologist who was the responsible of collecting data through the telephone interview or her medical history, did not know the treatment taken by the patient.

Comparative Analysis of Three Locoregional Anesthesia Methods in Breast Tumour Pathology Surgery

Compare pain management in immediate postoperative period: Which technique presents less pain in visual analogue scale (VAS score), and also comparing this VAS score obtained with the preoperative VAS collected (baseline VAS). VAS is a one-dimensional pain scale (0-no pain; 1-3 mild pain; 4-7 moderate pain; 8-10 severe pain).

Compare pain management in postoperative period (24 hours after surgery): Which technique presents less pain in visual analogue scale (VAS score), and also comparing this VAS score obtained with the preoperative VAS collected (baseline VAS). VAS is a one-dimensional pain scale (0-no pain; 1-3 mild pain; 4-7 moderate pain; 8-10 severe pain).

Compare pain management in postoperative period (3 months after surgery): Which technique presents less pain in visual analogue scale (VAS score), and also comparing this VAS score obtained with the preoperative VAS collected (baseline VAS). VAS is a one-dimensional pain scale (0-no pain; 1-3 mild pain; 4-7 moderate pain; 8-10 severe pain).

Compare pain management in postoperative period (1 year after surgery): Which technique presents less pain in visual analogue scale (VAS score), and also comparing this VAS score obtained with the preoperative VAS collected (baseline VAS). VAS is a one-dimensional pain scale (0-no pain; 1-3 mild pain; 4-7 moderate pain; 8-10 severe pain).

Which technique requires less opioid use; quantify opioid consumption in milligrams morphine equivalent (MME) and compare opioid consumption between the three study groups.

Researchers record the opioid use required by patients and the results are converted into MME to make comparison possible.

Comparing the incidence of need of analgesic treatment 1 year after surgery between the three study groups: according to the World Health Organization (WHO) analgesic ladder that patients received one year after surgery.

WHO analgesic ladder: Step I, treatment with paracetamol and NSAIDs. At step II, treatment with weak opioids; Step III, treatment with a strong opioid; Step IV, interventional pain techniques.

Hemodynamics defined by heart rate and non-invasive blood pressure changes that need to be controlled by drugs.

YES: patients present hemodynamic alterations (Mean arterial pressure \<65 mmHg or \>20% variation; heart rate \>100 heart beats per minute).

NO: patients do not present any hemodynamic alterations.

Quantify in hours the hospital stay length and compare results between the three study groups.

Analyze how many patients with chronic postsurgical pain are being followed by the Pain Unit.Compare the assistance needed between the three study groups

Breast CPP: patients with pain in the breast area and chest wall. Shoulder CPP: patients with ipsilateral shoulder and/or upper limb pain. Breast \& Shoulder CPP: patients who unify both locations described. Comparing locations incidence in three groups of study.

University of Valencia

Levobupivacaine

Intervention:30 ml of 0.25% Levobupivacaine where: ESP block as described by Forero at T5 level (single injection between transversour process and erector spinae muscles)

Intervention:30 ml of 0.25% Levobupivacaine where:PECS II block as described by Blanco.

local anesthetic will be injected between transverous process and erector spinae muscle

local anesthetic will be injected between pectoralis minor and pectoralis major (10 ml) and between pectoralis minor and serratus (20 ml)

PECS BLOCK

Alessandro De Cassai, MD

Backgroung:Regional anesthesia in breast surgery is of paramount importance to reduce pain in perioperative period.

PECS II block is an interfascial block that has been used widely as regional anesthesia technique in breast surgery.

ESP block is a novel interfascial block proposed in 2016 by Forero. Several reports used this technique in breast surgery to provide analgesia but to date no studies comparing these technique exists.

Our hypotesis is that this two technique are equally able to provide analgesia in breast surgery.

Study type: RCT, single blind.

This is a single-centre, prospective; double blinded randomised interventional clinical trial.

Patients will be randomly allocated to group "PECS" or "ESP" using a closed envelope technique.

Group "PECS" will receive PECS II block as described by Blanco using 30 ml Levobupivacaine 0.25% Group "ESP" will receive ESP block as described by forero using 30 ml Levobupivacaine 0.25% at T5 level.

Blocks will be executed after general anesthesia induction. All partecipants will receive Fentanyl 2 mcg/kg and Propofol 2 mg/kg for induction. Anesthesia will be mantained with Propofol to obtain a BIS level between 40-50. Patients will receive Fentanyl 33 mcg whenever blood pressure and/or hear rate raise more than 20% from baseline after surgical stimulation. At the end of the surgery patients will receive acetominophen 1 g. postoperative therapy: acetominophen 1g/8hr and ketoprofen 100 mg/12hr.

Patients will receive 2 mg Morphine whenever a NRS \> 3.

ESP block and PECS block will be executed by an anesthesiologist that will not follow the patient during the surgery.

Anesthesiologist responsible for the surgery will be not aware of the block executed on the patient Anesthesiologist and surgeon responsible for postoperative therapy will be not aware of the block executed on the patient

Comparison of Erector Spinae Plane Block With PECS II Block in Patients Undergoing Breast Cancer Surgery

Comparison of Erector Spinae Plane Block With PECS II Block in Patients Undergoing Breast Cancer Surgery:a Randomized Controlled Trial

Probably data will be shared at the end of the study

Intraoperative fentanyl dose (mcg) difference between ESP group and PECS group.

NRS (0-10) difference at sixth postoperative hour between ESP group and PECS group

NRS (0-10) difference at twelth postoperative hour between ESP group and PECS group

NRS (0-10) difference at twentyfourth postoperative hour between ESP group and PECS group

Patient satisfaction (0-10) difference regarding anesthesia management at twentyfourth postoperative hour between ESP group and PECS group

Time (minutes) to first opioid consumption in the postoperative period

postoperative morphine dose (mg) difference between ESP group and PECS group.

Incidence of nausea and vomiting in postoperative period

Incidence of other complcations linked to anesthesia in postoperative period

Intraoperative fentanyl dose (mcg/kg/h) difference between ESP group and PECS group.

University of Padova

Principal Investigator

Analgesics

Dexmedetomidine

Hypnotics and Sedatives

Analgesics, Non-Narcotic

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

participants will receive an ESP block with 20 ml Ropivacaine 0.375% in the induction room 20 minutes before their operation

participants will receive an ESP block with 20 ml Ropivacaine 0.375% + 0.5mcg/kg dexmedetomidine in the induction room 20 minutes before their operation

addition of dexmedetomidine to ropivacaine as an adjuvant in ESP block to assess wether or not it prolongs its duration of action

Yara Al Jalbout, MD

Hanane Barakat, MD

Sami Rizk

Patients undergoing Partial or total mastectomy with axillary LN dissection will receive prior to induction of general anaesthesia ESP block at T4 level at the same side of the surgery. one group will receive ropivacaine 0.375% and the other will get ropivacaine 0.375% with dexmedetomidine 0.5mcg/kg as an adjuvant. time to first narcotic requirement will be documented and therefore an assessment of the duration of action of the block will be made

Background and Objective: Whether partial or complete, mastectomy with axillary lymph node dissection is a painful surgery. Acute postoperative pain management is challenging and crucial due to high chances of it transforming into chronic pain. Erector spinae plane (ESP) block has been shown to be effective in managing post mastectomy pain.Dai et al showed the effectiveness of dexmedetomidine in prolonging the duration of sensory block, motor block and analgesia when dexmedetomidine as an adjunct is added to ropivacaine in brachial plexus block (1). The aim of our study is to show the effectiveness of dexmedetomidine in prolonging the analgesic effect of ropivacaine when added to it in ESP block compared to using ropivacaine alone in patients undergoing mastectomy with axillary lymph node dissection, and to study its impact on postoperative opioid consumption.

Methods: 44 American Society of Anesthesiologist (ASA) physical status classification class I, II and III will be randomly allocated to one of two groups, both receiving a single injection erector spinae plane block at T4 vertebral level using 20ml ropivacaine 0.375% 20 minutes before the induction of anesthesia. The first group will receive 0.5mcg/kg of dexmedetomdine added to the ropivacaine solution. The control group will receive no dexmedetomidine.

Postoperatively, patients in both groups will be receive acetaminophen 1g orally every 6 hours and oxycodone 5 mg orally as needed every 6 hours if VAS is more than 4. Postoperative pain will be measured using Verbal Analogue Scale (VAS) at 0, 1, 2, 4, 6, 12, 18, and 24 hours.

Conclusion: This study will be the first of its kind to investigate the impact of adding dexmedetomidine as an adjunct to ropivacaine in prolonging the ESP block duration in patients undergoing mastectomy with axillary lymph node dissection.

Effect of Dexmedetomidine on the Duration of Pain Control in ESP Block for Breast Surgery

Addition of Dexmedetomidine to Ropivacaine for Ultrasound Guided Erector Spinae Block: Evaluation of Effect on Postoperative Pain After Breast Surgery: A Double-Blinded, Prospective, Randomized Clinical Trial

Pain will be assessed using the VAS score ranging from 0, indicating no pain at all, to 10, indicating the worst pain the patient has ever felt

Lebanese American University

Clinical Instructor, Director Anaesthesiology Residency Program

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Thoracic Neoplasms

Anti-Arrhythmia Agents

Channel Blockers

Lidocaine

In patients randomized to this Arm, before the induction of general anesthesia, the epidural catheter is placed in the intervertebral space (T4-T5, T5-6 or T6-T7) and used intra and post-operatively for administration of local anesthetics.

In patients randomized to this Arm, after induction of general anesthesia the Erector spinae plane (ESP) block is performed with a catheter introduced and left in place for continuous postoperative infusion of local anesthetics.

In patients randomized to this Arm, after induction of general anesthesia and single lung ventilation the first thoracoscopic surgical access is performed. A cryoanesthesia device with a dedicated atraumatic angled-tip cryoprobe is inserted through the thoracoscopic access and the active tip of the probe is positioned in contact with the intercostal nerves from T3 to T8.

The epidural catheter is placed while the patient is awake, before the induction of general anesthesia. The intervertebral spaces used for catheter insertion are alternatively T4-T5, T5-6 or T6-T7. After locating the epidural space through the technique of the loss of resistance, a catheter is introduced for about 5 cm and left in place for the administration of drugs into the epidural space. Once the correct functioning of the epidural catheter has been verified with a negative test for cerebrospinal fluid aspiration and a negative bolus test for the onset of signs and symptoms from intrathecal infusion, the catheter is used intraoperatively for administration of local anesthetics in refracted boluses (Lidocaine and Ropivacaine ) at anesthetic dosage and postoperatively for continuous infusion of Ropivacaine 0.15% at 5 mL/h.

Epidural

Erector spinae plane (ESP) block is performed after induction of general anesthesia, with the patient in a lateral decubitus position. With the aid of the ultrasound guide with linear probe, the transverse process of T5 ipsilateral to the site of the operation is identified. With the in-plane technique, the lower fascia of the ESP muscle is hydrodissected through the administration of Ropivacaine 0.5% 3 mg/Kg lean body weight. Subsequently, a catheter is introduced and left in place for continuous postoperative infusion of Ropivacaine 0.2% at 12 mL/h.

ESP block

Cryoanalgesia is performed after the induction of general anesthesia, single lung ventilation and after performing the first thoracoscopic surgical access. A cryoanesthesia device with a dedicated atraumatic angled-tip cryoprobe is inserted through the thoracoscopic access. The active tip of the probe is positioned in contact with the intercostal nerves from T3 to T8 and kept resting for 4 ½ minutes on each nerve at a temperature of -70°C, under direct thoracoscopic vision, generating an interruption of the sensory functions.

Cryoanalgesia

MARCO MAMMANA, MD, PhD

MARCO MAMMANA, MD,PhD

In patients undergoing minimally invasive thoracoscopic surgery (video-assisted thoracoscopic surgery, or VATS), moderate to severe post-operative pain may often be experienced. The presence of pain negatively affects the perceived quality of care and can predispose to complications, as the development of chronic pain.

In order to prevent post-operative pain, different multimodal pain treatment protocols are applied, consisting in combinations of local-regional anesthesiological techniques and intravenous medications.

Regional anesthesia is considered essential to prevent pain in the immediate post-operative period. However, to date, there is no agreement regarding which is the most effective regional anesthesiological technique; therefore, the choice is usually based on the Anesthetist's preferences.

The aim of this study is to compare three regional anesthesiological techniques (cryoanalgesia, epidural anesthesia, and erector spinae muscle plane block) routinely used during thoracoscopic lung surgery.

In patients undergoing minimally invasive thoracoscopic surgery (video-assisted thoracoscopic surgery, or VATS), moderate to severe post-operative pain may often be experienced. The presence of pain negatively affects the perceived quality of care and can predispose to complications, as the development of chronic pain.

In order to prevent post-operative pain, different multimodal pain treatment protocols are applied, consisting in combinations of local-regional anesthesiological techniques and intravenous medications.

Regional anesthesia is considered essential to prevent pain in the immediate post-operative period. However, to date, there is no agreement regarding which is the most effective regional anesthesiological technique; therefore, the choice is usually based on the Anesthetist's preferences.

The aim of this study is to compare three regional anesthesiological techniques (cryoanalgesia, epidural anesthesia, and erector spinae muscle plane block) routinely used during thoracoscopic lung surgery.

All patients undergoing anatomical pulmonary resections (lobectomy or segmentectomy) through a thoracoscopic (VATS) approach, and who present the inclusion/exclusion characteristics, will be considered.

The day of surgery, patients are randomized 1:1:1 to receive 3 different pain control techniques: epidural catheter, ESP block or cryoanalgesia.

A standard pain management protocol will be applied to all patient after surgery.

Primary Outcome Measure is the perceived post-operative pain 24 hours after surgery in the 3 groups, evaluated through numeric pain rating scale (NPRS). Other outcome measures are the post-operative pain trend and the patients' total amount of opioid use in the postoperative period (expressed as Morphine milligram equivalents).

Pain Control After VATS Anatomical Pulmonary Resections

Pain Control After VATS Anatomical Pulmonary Resections: Randomized Comparison Between Cryoanalgesia, Erector Spinae Plane Block and Epidural Catheter

Perceived post-operative pain 24 hours after surgery through Numeric Pain Rating Scale (NPRS, value from 0 to 10, o=no pain, 10=worst pain ever)

Perceived post-operative pain 1,6,12 and 48 hours after surgery through Numeric Pain Rating Scale (NPRS, value from 0 to 10, o=no pain, 10=worst pain ever)

patients' total amount of opioid use in the postoperative period (expressed as Morphine milligram equivalents)

University Hospital Padova

Thoracic Surgeon

Lung Diseases

Respiratory Tract Diseases

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

Vasoconstrictor Agents

Respiratory System Agents

Dexamethasone

Epinephrine

Dexamethasone acetate

Racepinephrine

Epinephryl borate

BB 1101

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Adrenergic beta-Agonists

Bronchodilator Agents

Anti-Asthmatic Agents

Mydriatics

Sympathomimetics

patients will receive an ultrasound guided ESP block (technique as described by Forero et al) under strict sterile conditions in the operating room area. After identifying the T5 transverse process (TP) and after infiltration of lidocaine 2% subcutaneously. A 22g 100mm block needle will be advanced under vision, in a cephalad to caudad direction, until the tip contacts the T5 TP. 20 ml of 0.25% bupivacaine with 5 mcg/ml of epinephrine and 10 mg dexamethasone will be injected under the erector spinae muscle. A visible separation of the erector spinae muscle from the TP will be the sign of a successful block. A 20 ml syringe of Normal Saline will be given to the surgeon (unaware of the content) at the end of the surgery, for the intercostal nerve block as per standard present technique.

patients will receive an ultrasound guided sham ESP block under strict sterile conditions in the operating room area as described above. 20 ml of Normal Saline will be injected under the erector spinae muscle. A 20 ml syringe of 0.25% bupivacaine with 5 mcg/ml of epinephrine and 10 mg dexamethasone will be given to the surgeon (blinded to the content) at the end of the surgery for the intercostal nerve block.

ESP with 20 ml of Bupivacaine 0.25%, Epinephrine 5mcg/ml and Dexamethasone 10mg.

Sham intercostal block with 20 ml Normal Saline

Intercostal block with 20 ml of Bupivacaine 0.25%, Epinephrine 5mcg/ml and Dexamethasone 10mg.

Sham ESP with 20 ml Normal Saline

Intercostal block

Sham ESP block

Sham Intercostal block

Bupivacaine-epinephrine

Dexamethasone injection

Normal saline

The Erector Spinae Plane (ESP) block is a new interfascial regional anesthesia technique recently described by Forero et al. Currently the literature shows the ESP block being used for analgesia after thoracic surgery, breast surgery, abdominal surgery (visceral abdominal analgesia in bariatric surgery, ventral hernia repair, cholecystectomy), thoracic vertebral surgery and for pain relief in rib fractures. Taking in consideration the excellent clinical experience, but the lack of strong and high-quality evidence, supporting the use of ESP block for pain management in patients undergoing VATS procedures, there is a specific interest to develop a prospective study. Comparing the effect of the current pain relief strategy at the MGH (intercostal nerve block by the surgeon at the end of the procedure ) versus ESP block after VATS, seems warranted to improve current clinical results.

In recent years, Video-Assisted Thoracic surgeries (VATS) has become the preferred approach for thoracic surgeries over thoracotomies, due to its clear advantages, such as improved pulmonary function, rapid recovery and reduced pain scores postoperatively. Although pain is reduced in VATS when compared to conventional thoracotomies, patients still experience moderate to severe pain, mainly due to intercostal nerve damage by ports and drains, as well as the surgical resection itself. Adequate pain relief leads to earlier and better mobilization, improves respiratory functions, and decreases global stress response. In addition, it helps in reducing the chances of developing chronic postoperative pain.

Epidural blockade has been recognized as the gold standard for analgesia in thoracic surgeries, with paravertebral blocks (PVB) replacing that standard in VATS procedures, due it's less deleterious adverse effects. Nevertheless, paravertebral blockade still poses some adverse effects such as pneumothorax and the risk of an epidural blockade. Moreover, it might prove difficult to perform in the untrained hand. Thus, a simpler blockade is warranted in patients undergoing VATS.

Proper pain relief is critical in the early postoperative period in VATS surgery, to allow early discharge of patients according to the clinical pathway milestones. The excessive consumption of opioids to achieve this goal on the other hand, may produce complications and side effects not compatible with the early discharge plan.

The Erector Spinae Plane (ESP) block is a new interfascial regional anesthesia technique recently described by Forero et al . It consists of injecting 20 ml of local anesthetic (ie.: ropivacaine 0.5%), under ultrasound guidance, at the level of the T5 transverse process in the tissue plane deep to the erector spinae muscle. A study on the ESP block was conducted on fresh human cadavers; dye mixture was injected deep to erector spinae muscle, and the spread showed to be cranio-caudal from C7 to T8, lateral spread extended to the tips of the transverse processes at all levels, penetration of the dye was beyond the costotransverse junction and anteriorly into the inter transverse spaces. In addition, there was evidence of dye penetration deep to the intercostal muscles and into the immediate vicinity of the ventral and dorsal rami of the spinal nerve roots. The authors discussed the most significant advantage of the ESP block is its simplicity and safety. The sonoanatomy is easily recognizable, there are no structures at risk of needle injury in the immediate surroundings (lower risk of nerve damage and pneumothorax), and is probably safer for patients with coagulation disorders. The technique also allows the insertion of an indwelling catheter to extend the duration of analgesia as needed.

Currently the literature shows the ESP block being used for analgesia after thoracic surgery, breast surgery, abdominal surgery (visceral abdominal analgesia in bariatric surgery, ventral hernia repair, cholecystectomy), thoracic vertebral surgery and for pain relief in rib fractures.

Taking in consideration the excellent clinical experience, but the lack of strong and high-quality evidence, supporting the use of ESP block for pain management in patients undergoing VATS procedures, there is a specific interest to develop a prospective study. Comparing the effect of the current pain relief strategy at the MGH (intercostal nerve block by the surgeon at the end of the procedure ) versus ESP block after VATS, seems warranted to improve current clinical results.

In this randomized controlled trial, the investigator hypothesize that a single injection ESP block, would provide an effective post operative pain relief, superior to an intercostal nerve block, in patients undergoing VATS procedures.

The study will be conducted at the Montreal General Hospital, one hundred patients; ASA I-III male and female patients aged between 18 to 80 years old, who are scheduled for Video assisted thoracic surgery. Patients will be recruited before surgery. Informed consent will be obtained by a Research Assistant.

Patients will be prospectively randomized in a double blind fashion, using a computer-generated number placed in a sealed brown envelope, into either group 1, receiving ESP block, or group 2, receiving sham ESP block.

In group 1, patients will receive an ultrasound guided ESP block (technique as described by Forero et al) under strict sterile conditions in the operating room area. After identifying the T5 transverse process (TP) and after infiltration of lidocaine 2% subcutaneously. A 22g 100mm block needle will be advanced under vision, in a cephalad to caudad direction, until the tip contacts the T5 TP. 20 ml of 0.25% bupivacaine with 5 mcg/ml of epinephrine and 10 mg dexamethasone will be injected under the erector spinae muscle. A visible separation of the erector spinae muscle from the TP will be the sign of a successful block. A 20 ml syringe of Normal Saline will be given to the surgeon (unaware of the content) at the end of the surgery, for the intercostal nerve block as per standard present technique.

In group 2, patients will receive an ultrasound guided sham ESP block under strict sterile conditions in the operating room area as described above. 20 ml of Normal Saline will be injected under the erector spinae muscle. A 20 ml syringe of 0.25% bupivacaine with 5mcg/ml of epinephrine and 10 mg dexamethasone will be given to the surgeon (blinded to the content) at the end of the surgery for the intercostal nerve block.

All medications will be prepared by a research assistant not assigned to the case, and not involved in the follow up assessment. Two 20 ml syringes will be prepared under sterile precautions, one containing Bupivacaine 0.25% with epinephrine 5 µg/ml and 10 mg dexamethasone, and the other containing 0.9% normal saline. Syringes will be labeled as "ESP" and "intercostal" according to the randomization. The evaluator in the postoperative period, the anesthesiologist, the patient and the surgeon will be blinded to the group randomization.

General anesthesia will be induced with propofol 1.5-2 mg/kg and fentanyl 2 mcg/kg, as well as rocuronium 0.6 mg/kg to facilitate tracheal intubation with a double lumen tube (DLT). A 3.2 mm fiberoptic bronchoscope will be used to confirm correct placement of the DLT, to allow one lung ventilation intraoperatively. Anesthesia will be maintained with sevofluorane or desflourane according to the anesthesiologist's preference.

For intra-operative analgesic requirements, Specific instructions will be handed to each anesthetist to administer fentanyl 25 mcg increments every 5 minutes in the following scenarios:

Elevation in the heart rate of more than 20% of baseline values. Elevation in blood pressure of more than 20% of baseline values.

Patients will receive Ondansetron 4mg prior to extubation. Post anesthetic care and medications will include.

Acetaminophen 975mg, PO or PR, Q6H Celecoxib 100mg, PO, BID for 5 days Ondansetron 4mg, PO or IV, Q8H, PRN (for nausea or vomiting) Nalbuphine 2.5 mg, IV, diluted PRN (for pruritus) Polyethylene glycol 17gr, PO, Day, PRN (for constipation)

All patients enrolled will be provided with a Patient Controlled Analgesia (PCA) pump for first 24 hours after the surgery. The pump will be programmed to deliver Morphine sulfate 1mg, lockout time 7 min, without a continuous infusion rate, capable to be increased to 1.5mg if pain VAS≥7 with the absence of sign or symptoms of toxicity. Hydromorphone will be used in case of Morphine allergy. Patients will be clearly instructed to trigger the PCA Only if they perceive pain as \>4/10 If the PCA IV line gets lost with failure to obtain a new one, in patients with VSA\>4, a rescue dose 3-5mg morphine SC Q4H PRN will be considered. The time and dose of rescue medication will be recorded.

The Standard Institutional Postoperative Clinical Pathway will be followed in both groups, except for the use of PCA.

Erector Spinae Plane Block Versus Intercostal for VATS

Ultrasound-Guided Erector Spinae Plane Block Versus Intercostal Nerve Block For Postoperative Pain Control in Video-Assisted Thoracoscopic Surgery: A Prospective, Double Blind Randomized Controlled Trial

measured by total intravenous morphine consumption at 24 hours postopertively. A 25% reduction in morphine consumption would be considered statistically significant.

Pain levels will be assessed using the 10 points Numerical Rating Scale (NRS) where zero= no pain and 10= pain as bad as it can be. The NRS is a validated tool to measure pain and discomfort. It is sensitive to pharmacological and non-pharmacological interventions, that have an impact over the experience of pain, as well as it's high correlation with pain levels

This will be assessed using the incentive spirometer, which allows for crude measurement of inspired volumes

postoperative nausea and vomiting (PONV), hypotension, urinary retention (requiring placement of an indwelling or a temporary catheter), pruritis and oxygen requirements

total time spent in the PACU until reaching PACU discharge criteria

total time spent in the hospital until reaching hospital discharge criteria

The time it takes to perform the ESP block

Incidence of block related adverse events such as bleeding, pneumothorax and local anesthetic systemic toxicity

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery	NCT05558917	Breast Cancer Breast Neoplasm... Breast Carcinom...	PECS BLOCK 2 ESP BLOCK	18 Years -	Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Comparative Analysis of Three Locoregional Anesthesia Methods in Breast Tumour Pathology Surgery	NCT05185752	Postoperative P... Chronic Post Op... Breast Tumor Locoregional An... Breast Pain	SIFP Block Loco... PECS II block: ... ESP block: Loco...	-	University of Valencia
Comparison of Erector Spinae Plane Block With PECS II Block in Patients Undergoing Breast Cancer Surgery	NCT03811262	Breast Cancer Anesthesia, Loc...	ESP BLOCK PECS BLOCK	18 Years - 90 Years	University of Padova
Effect of Dexmedetomidine on the Duration of Pain Control in ESP Block for Breast Surgery	NCT04029467	Breast Cancer Mastectomy Axillary Lymph ... Pain, Postopera...	Dexmedetomidine	18 Years - 80 Years	Lebanese American University
Pain Control After VATS Anatomical Pulmonary Resections	NCT05993273	Lung Cancer Pain, Postopera... Thoracic Neopla...	Epidural ESP block Cryoanalgesia	18 Years -	University Hospital Padova
Erector Spinae Plane Block Versus Intercostal for VATS	NCT03902782	Lung Cancer Lung Diseases	ESP block Intercostal blo... Sham ESP block Sham Intercosta... Bupivacaine-epi... Dexamethasone i... Normal saline	18 Years - 80 Years	McGill University Health Centre/Research Institute of the McGill University Health Centre

Spots Global Cancer Trial Database for esp block

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Spots Global Cancer Trial Database for esp block

Every month we try and update this database with for esp block cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for esp block cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.