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Ketorolac

will receive pre-operative ultrasound guided stellate ganglion block one hour before surgery and multimodal analgesia and will be followed for 6 months for neuropathic pain as the Stellate Group

will receive multimodal analgesia only and will be followed for 6 months for neuropathic pain as the control Group

Using US with a linear array transduce, subfascial-C6- Stellate Ganglion Block. Patients will be supine with the neck slightly hyper- extended. After aseptic preparation of the skin, the transducer is placed on the neck to enable cross sectional visualization of anatomical structures at the level of C6. The carotid artery, internal jugular vein, thyroid gland, trachea, longus colli covered with the prevertebral fascia, root of C6, and transverse process of C6 are all visualized. The transducer will then gently be pressed between the carotid artery and trachea to retract the carotid artery laterally and to position the transducer close to the longus colli.

A 1.0-inch, 25-gauge long-bevel needle were paratracheal inserted toward the middle of the longus colli. The endpoint for injection were the ultrasound image demonstrating the tip of needle penetrating the prevertebral fascia in the longus colli. After negative aspiration, 5 mL of 0.5% bupivacaine was injected

Stellate Ganglion Block

Multimodal analgesia in the form of administering of IV paracetamol 1000 mg one hour prior to start of surgery in combination 30 mg ketorolac and Single preoperative 0.1 mg/kg dose dexamethasone has a combined action, anti-emetic and provides enhanced analgesia, with intra-operative fast acting opioid analgesics, Fentanyl 2 mic/kg

Multimodal Analgesia

Ahmed Salman, MSC

Ahmed Abdelgalil, MD

Ahmed Salah, MD

Ahmed Salman

This study investigate the effect of pre-operative ultrasound guided stellate ganglion block with local anesthetic on the frequency of neuropathic pain syndromes in the first 6-month post cancer breast surgeries with axillary dissection.

In this study Eighty Female patients with a diagnosis of breast cancer, underwent breast surgery with axillary dissection at National Cancer Institute, Cairo University were included in this study. Patients will be randomized into two equal comparable groups of patients.

(Group A the study group) was received pre-operative ultrasound guided stellate ganglion block one hour before surgery and multimodal analgesia and (Group B the control group) was received multimodal analgesia only.

The present study showed in regards to the acute pain management of the stellate ganglion block: intraoperative hemodynamics, mean arterial blood pressure and heart rate (MABP, HR) were statistically significant less in group A (Stellate Group) than group B (Control Group) and this leads to significant less opioid consumption in Group A (Stellate Group) than Group B (Control group). In the 1st 24h postoperative opioid consumption measured by number of rescue dose of morphine 5mg IV were administered when visual analogue score was more than 4 and total requirement per 24 hours was recorded. The results show statistically significant less opioid consumption in Group A (Stellate Group) with average visual analogue score 3.5 in 1st 24h than Group B (Control group) with average visual analogue score 5.5 in 1st 24h.

The present study showed in regards to the chronic pain management of the stellate ganglion block that, the 6-month relative frequency of neuropathic pain syndromes, using the grading system for neuropathic pain (GSNP) shows statistically significance lower frequency of neuropathic pain syndromes in Group A (Stellate Group) than Group B (Control group).

Assessment of patient daily activity and functional capacity using Eastern cooperative oncology group (ECOG) scoring showed statistically significance higher performance status (lower numbers in the score) in Group A (Stellate Group) than Group B (Control group).

Number of patients discharged on tramadol \& or Lyrica whom developed Post Mastectomy Pain syndrome (PMPs) is statically significant lower in Group A (Stellate Group) than Group B (Control group).

Post Mastectomy Pain Syndrome After Preoperative Stellate Ganglion Block for Breast Cancer Surgeries

Evaluation of Post Mastectomy Pain Syndrome After Preoperative Stellate Ganglion Block for Breast Cancer Surgeries, Clinical Randomized Controlled Trial

relative frequency of neuropathic pain syndromes post breast surgeries with axillary dissection after preoperative ultrasound stellate ganglion block. This is accomplished using the grading system for neuropathic pain (GSNP),0: No Pain,1: Pain, 2: Possible neuropathic: Pain with (A history of relevant neurological lesion or disease AND Pain distribution neuroanatomically plausible, 3: Pain Probable neuropathic: Positive sensory signs (allodynia, hyperalgesia, electric, burning, numbness, itching, maybe motor or autonomic changes) on the distribution of the injured nerves or beyond, 4: Pain Definitive neuropathic: diagnostic test confirms the lesion or disease of the somatosensory nervous system OR a surgeon's clear verification of an intraoperative nerve lesion (intercostobrachial in MRM with Axillary Evacuation in Breast Surgery)

Assessment of patient daily activity and functional capacity is evaluated using Eastern cooperative oncology group "ECOG" scoring, (0=fully active, 1= able to perform light effort, 2= in bed \<50% of the day 3=in bed \>50% of the day, 4=bed ridden, 5=died) so the low score the better.

opioid consumption using the Visual analogy scale (VAS) score,Post-operative opioid consumption measured by number of rescue dose of morphine 5mg IV administered when VAS was more than 4 and total requirement per 24 hours was recorded.

National Cancer Institute, Egypt

Aneasthetist

Rare Diseases

Pain, Postoperative

Postoperative Complications

Chronic Graft Versus Host Disease

Anesthetics

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

Behaviors and Mental Disorders

Respiratory Tract (Lung and Bronchial) Diseases

Anxiety Disorders

Respiratory Aspiration

Acute Graft Versus Host Disease

As part of usual care, participants will be provided with headphones to listen to music during the biopsy procedure. Music options will include instrumental jazz, classical piano, harp and flute, and world music.

Participants in the controlled breathing intervention will be provided with headphones to listen to the guided intervention audio file. Over the course of the 25-60-minute procedure, approximately 50% of the intervention will be spent completing controlled breathing. The other 50% of the intervention will be spent listening to music, which is part of usual care. Music options will include instrumental jazz, classical piano, harp and flute, nature sounds, and world music.

Participants in the controlled breathing intervention will be provided with headphones to listen to the guided intervention audio file. The intervention will guide participants to breathe at a rate of six breaths per minute (approximately 50% of their normal breathing rate).

Controlled Breathing Intervention

Rebecca Shelby, Ph.D.

The proposed randomized study evaluates whether a controlled breathing intervention could be efficacious for reducing pain in the MRI-guided breast biopsy setting. Support for this intervention stems from experimental and clinical studies on the effects of controlled breathing on pain. Implementing a controlled breathing intervention during MRI-guided breast biopsy has the potential to provide effective pain management in this outpatient setting. The primary study objectives are to assess the feasibility, acceptability, and efficacy of a novel audio-recorded controlled breathing intervention for reducing breast and body pain in women undergoing MRI-guided breast biopsy. The secondary study objectives are to evaluate the effects of controlled breathing on measures of physiological reactivity (i.e., blood pressure and heart rate), pain catastrophizing, and self-efficacy for pain and anxiety.

Both conditions receive audio-recordings, and the radiologist care providers are blinded to the audio recordings participants receive.

Participants must be women undergoing MRI-guided breast biopsies at the Duke Cancer Institute.

Calming Alternatives Learned During MRI-Guided Breast Biopsy

Calming Alternatives Learned During MRI-Guided Breast Biopsy (CALM)

Body pain pre-biopsy will be will be assessed using four questions from the Brief Pain Inventory (BPI) Pain Severity Scale. Women will be asked to rate 1) worst, 2) least, and 3) average body pain during the past week, as well as 4) current body pain on a scale from 0 (no pain) to 10 (pain as bad as it could be). Consistent with BPI scoring, items will be averaged to create a composite score that had a possible range of 0 to 10 with higher scores indicating greater pain.

Breast pain pre-biopsy will be will be assessed using four questions from the Brief Pain Inventory (BPI) Pain Severity Scale. Women will be asked to rate 1) worst, 2) least, and 3) average breast pain during the past week, as well as 4) current breast pain on a scale from 0 (no pain) to 10 (pain as bad as it could be). Consistent with BPI scoring, items will be averaged to create a composite score that had a possible range of 0 to 10 with higher scores indicating greater pain.

Body pain after positioning on the MRI table for the biopsy procedure will be will be assessed using a verbally-administered numerical rating scale (NRS) that ranges from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater pain.

Breast pain after each superficial local anesthetic injection during the biopsy procedure will be will be assessed using a verbally-administered numerical rating scale (NRS) that ranges from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater pain.

Breast pain after each deeper local anesthetic injection during the biopsy procedure will be will be assessed using a verbally-administered numerical rating scale (NRS) that ranges from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater pain.

Body pain after the last introducer is inserted will be will be assessed using a verbally-administered numerical rating scale (NRS) that ranges from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater pain.

Breast pain after the last tissue sampling at each biopsy site will be will be assessed using a verbally-administered numerical rating scale (NRS) that ranges from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater pain.

Body pain after the last introducer sheath is removed will be will be assessed using a verbally-administered numerical rating scale (NRS) that ranges from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater pain.

Body pain post-biopsy will be will be assessed using four questions from the Brief Pain Inventory (BPI) Pain Severity Scale. Women will be asked to rate 1) worst, 2) least, and 3) average body pain during the biopsy procedure, as well as 4) current body pain on a scale from 0 (no pain) to 10 (pain as bad as it could be). Consistent with BPI scoring, items will be averaged to create a composite score that had a possible range of 0 to 10 with higher scores indicating greater pain.

Breast pain post-biopsy will be will be assessed using four questions from the Brief Pain Inventory (BPI) Pain Severity Scale. Women will be asked to rate 1) worst, 2) least, and 3) average breast pain during the biopsy procedure, as well as 4) current breast pain on a scale from 0 (no pain) to 10 (pain as bad as it could be). Consistent with BPI scoring, items will be averaged to create a composite score that had a possible range of 0 to 10 with higher scores indicating greater pain.

Body pain 24 hours post-biopsy will be will be assessed using four questions from the Brief Pain Inventory (BPI) Pain Severity Scale. Women will be asked to rate 1) worst, 2) least, and 3) average body pain in the 24 hours post-biopsy, as well as 4) current body pain on a scale from 0 (no pain) to 10 (pain as bad as it could be). Consistent with BPI scoring, items will be averaged to create a composite score that had a possible range of 0 to 10 with higher scores indicating greater pain.

Breast pain 24 hours post-biopsy will be will be assessed using four questions from the Brief Pain Inventory (BPI) Pain Severity Scale. Women will be asked to rate 1) worst, 2) least, and 3) average breast pain in the 24 hours post-biopsy, as well as 4) current breast pain on a scale from 0 (no pain) to 10 (pain as bad as it could be). Consistent with BPI scoring, items will be averaged to create a composite score that had a possible range of 0 to 10 with higher scores indicating greater pain.

To indicate the number of pre-biopsy body pain sites, participants will complete a full body map, indicating the locations of body pain.

To indicate the number of pre-biopsy breast pain sites, participants will complete a breast map (showing the chest, shoulders, and upper arms), indicating the locations of breast pain.

Prior to biopsy, one question will be asked to assess anticipated body pain (i.e., "How much body pain do you think you will experience during the biopsy today?") on a scale from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater anticipated pain.

Prior to biopsy, one question will be asked to assess anticipated breast pain (i.e., "How much breast pain do you think you will experience during the biopsy today?") on a scale from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater anticipated pain.

The State Anxiety Scale of the State-Trait Anxiety Inventory (STAI) will assess the degree of anxiety pre-biopsy. Participants will rate each of the 20 items on a 5-point Likert scale, ranging from 1 (not at all) through 4 (very much). Items will be summed, creating a total score (possible range: 20-80).

Likelihood of cancer will be assessed pre-biopsy using a 1 single-item scale. Participants will be asked to indicate what they were told regarding the likelihood of cancer from their recommending radiologist on a scale from 0 (not applicable - they did not discuss this with me) to 5 (high likelihood of cancer) with higher scores indicating a greater likelihood of cancer.

To assess the use of pain coping strategies pre-biopsy, participants will complete the 14-item Coping Strategies Questionnaire (CSQ). Participants will rate how frequently they use seven pain coping strategies (two items per scale) on a scale ranging from 0 (not at all) to 6 (a lot). Items will be averaged, giving a total score on each scale ranging from 0 to 6 with higher scores indicating greater use of pain coping strategies.

To assess self-efficacy for managing pain and anxiety pre-biopsy, participants will complete a 4-item scale. Items will be rated on a 10-point scale from 1 (not certain) to 10 (very certain). Items will be averaged to create a composite score, ranging from 0 to 10 with higher scores indicating greater self-efficacy.

Blood pressure (systolic/diastolic) pre-biopsy will be measured using an MRI-compatible blood pressure cuff.

Heart rate pre-biopsy will be measured using an MRI-compatible pulse oximeter.

Blood pressure (systolic/diastolic) after positioning on the MRI table will be measured using an MRI-compatible blood pressure cuff.

Heart rate after positioning on the MRI table will be measured using an MRI-compatible pulse oximeter.

Blood pressure (systolic/diastolic) after the last introducer is inserted will be measured using an MRI-compatible blood pressure cuff.

Heart rate after the last introducer is inserted will be measured using an MRI-compatible pulse oximeter.

Blood pressure (systolic/diastolic) after the last introducer sheath is removed will be measured using an MRI-compatible blood pressure cuff.

Heart rate after the last introducer sheath is removed will be measured using an MRI-compatible pulse oximeter.

The State Anxiety Scale of the State-Trait Anxiety Inventory (STAI) will assess the degree of anxiety post-biopsy. Participants will rate each of the 20 items on a 5-point Likert scale, ranging from 1 (not at all) through 4 (very much). Items will be summed, creating a total score (possible range: 20-80).

Likelihood of cancer will be assessed post-biopsy using a single-item scale. Participants will be asked to indicate what they were told regarding the likelihood of cancer from the radiologist performing the biopsy on a scale from 0 (not applicable - they did not discuss this with me) to 5 (high likelihood of cancer).

Using a 2-item self-report measure, participants will rate 1) the amount of attention they paid to the pain during biopsy and 2) the extent to which they were able to distract themselves from the pain during biopsy on an 11-point scale, ranging from 0 (not at all) to 10 (very much). An ''attention to pain" score (range -10 to +10) will be calculated by subtracting the ability to distract from pain from the amount of attention to pain. The higher the score, the more attention paid to pain.

Participants will also be asked to rate how much time they spent thinking about pain during the biopsy procedure on an 11-point scale, ranging from 0 (none of the time) to 10 (all of the time).

Participants will be asked to indicate how relaxed they were during the biopsy procedure on a scale, ranging from 0 (not relaxed) to 10 (extremely relaxed).

Participants will also be provided with a list of six adjectives (i.e., tense, on-edge, uneasy, restless, nervous, and anxious) from the Tension Subscale of the Profile of Mood State Short-Form and be asked to rate each of the adjectives on a 5-point Likert scale, ranging from 0 (not at all) to 4 (extremely).

To assess the use of pain coping strategies during the biopsy procedure, participants will complete the 14-item Coping Strategies Questionnaire (CSQ). Participants will rate how frequently they used seven pain coping strategies (two items per scale) during the procedure on a scale ranging from 0 (not at all) to 6 (a lot). Items will be averaged, giving a total score on each scale ranging from 0 to 6 with higher scores indicating greater use of pain coping strategies.

To assess self-efficacy for managing pain and anxiety during the biopsy procedure, participants will complete a 4-item scale. Items will be rated on a 10-point scale from 0 (not certain) to 10 (very certain). Items will be averaged to create a composite score, ranging from 0 to 10 with higher scores indicating greater self-efficacy.

The State Anxiety Scale of the State-Trait Anxiety Inventory (STAI) will assess the degree of anxiety 24 hours post-biopsy. Participants will rate each of the 20 items on a 5-point Likert scale, ranging from 1 (not at all) through 4 (very much). Items will be summed, creating a total score (possible range: 20-80).

Duke University

Peripheral Nervous System Diseases

Neuromuscular Diseases

Anti-Arrhythmia Agents

Channel Blockers

Lidocaine

Anesthetics, Local

Sodium Channel Blockers

Diuretics, Potassium Sparing

Drug: lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 1 patch was applied topically to the affected site(s) for 12 hours each day.

Drug: placebo patch, 1 patch was applied topically to the affected site(s) for 12 hours each day.

1 patch was applied topically to the affected site(s) for 12 hours each day.

Lidoderm patch

Placebo patch

This trial is part of a larger, longitudinal study of symptoms that occur in the breast surgical scar area and/or ipsilateral arm following breast cancer surgery. Women who develop pain in the breast scar area or ipsilateral arm will be randomized to a placebo patch or a lidocaine patch that they will wear on a daily basis for 12 weeks. We hypothesize that women who wear the lidocaine patch will report a decrease in pain and decreased interference with function compared to women who wear the placebo patch.

Symptom Management After Breast Cancer Surgery

A Randomized, Double-Blind, Placebo-Controlled Trial (RDBPCT) of the Effectiveness of the Lidocaine Patch in the Management of Neuropathic Pain After Breast Cancer Surgery

Patients scored their pain intensity in the breast and/or ipsilateral arm using a 0 to 10 numeric rating scale, ranging from no pain (0) to worst pain imaginable (10). The change in pain intensity was calculated from two time points as the later time point (12 weeks) minus the earlier time point (Baseline).

University of California, San Francisco

Lidocaine patch One patch is changed every twenty-four hours

Lidocaine Patch

Placebo patch: Patch is changed every 24 hours

Placebo Patch

Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day.

Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.

Total

Age, Continuous

Sex: Female, Male

White

Black

Asian/Pacific Islander

Hispanic or Mixed Ethnic Background

Race/Ethnicity, Customized

United States

Region of Enrollment

Patients scored their pain intensity in the breast and/or ipsilateral arm at enrollment using a 0 to 10 numeric rating scale, ranging from no pain (0) to worst pain imaginable (10)

Average pain intensity

Worst pain intensity

Dr. Christine Miaskowski, PI

This study attempted to evaluate changes in average pain intensity following breast cancer surgery. However, since none of the patients in the lidocaine group completed the 12 week trial, the outcomes of this study cannot be evaluated.

Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks

Pain Interference With Function

Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 1 patch was applied topically to the affected site(s) for 12 hours each day.

Overall Study

Chronic Pain

Rodney A Gabriel, MD, MAS

Rodney A Gabriel, MD

Breast surgery, which includes mastectomy, breast reconstructive surgery, or lumpectomies with sentinel node biopsies, may lead to the development of chronic pain and long-term opioid use. In the era of an opioid crisis, it is important to risk-stratify this surgical population for risk of these outcomes in an effort to personalize pain management. The opioid epidemic in the United States resulted in more than 40,000 deaths in 2016, 40% of which involved prescription opioids. Furthermore, it is estimated that 2 million patients become opioid-dependent after elective, outpatient surgery each year. After major breast surgery, chronic pain has been reported to develop anywhere between 35% - 62% of patients, while about 10% use long-term opioids. Precision medicine is a concept at which medical management is tailored to an individual patient based on a specific patient's characteristics, including social, demographic, medical, genetic, and molecular/cellular data. With a plethora of data specific to millions of patients, the use of artificial intelligence (AI) modalities to analyze big data in order to implement precision medicine is crucial. We propose to prospectively collect rich data from patients undergoing various breast surgeries in order to develop predictive models using AI modalities to predict patients at-risk for chronic pain and opioid use.

The primary objective of this is to develop predictive models using artificial intelligence algorithms to predict acute and chronic pain and opioid use in patients undergoing breast surgery. Development of these models will involve prospectively collecting data from this surgical population, including: 1) survey results from the Brief Pain Inventory, Fibromyalgia Survey Criteria, and PROMIS scales (depression scale, anxiety scale, physical function scale, fatigue scale, sleep disturbance scale); 2) pharmacogenomics (single nucleotide peptides from COMT, BDNF, SCN11a, OPRM1, ABCB1, CYPD26, and CYP34A, to name a few); 3) preoperative comorbidities (including but not limited to diabetes mellitus, chronic pain, psychiatric disorders, substance abuse history, obstructive sleep apnea, etc); 4) preoperative labs (i.e. hemoglobin); 5) demographic data (i.e. socioeconomic status, religion, ethnicity; primary language spoken, age, body mass index, sex, etc); 6) preoperative medication use; 7) primary surgical diagnosis; 8) surgery; and 9) social support system. Intraoperative data will include: 1) primary anesthetic type; 2) case duration; 3) total opioid use; 4) non-opioid analgesic use; 5) heart rate hemodynamics; and 6) blood pressure hemodynamics. Postoperative data will include: 1) total opioid use; 2) discharge medications; 3) hospital length of stay; 4) pain scores; 5) postoperative vital signs (blood pressure, heart rate); and 6) participation with physical therapy. The primary outcome measures will be opioid use in the acute period and chronic postoperative stage (30 and 90 days and 6 months) and development of chronic pain (up to 6 months after surgery). The model with the best performance will be used to develop a predictive analytic system aimed to identify high risk opioid patients in order to allocate expert pain management resources to those patients. We hypothesize that we can develop an accurate model for identifying high risk opioid users and patients at-risk for chronic pain in these surgical populations and subsequently implement a predictive analytic system that can detect these patients early-on.

We will collect buccal swab specimens from patients for pharmacogenomic screening

Predicting Chronic Pain Following Breast Surgery

Development of Predictive Models Using Artificial Intelligence for Postoperative Chronic Pain and Opioid Use Following Breast Surgery: A Prospectively-Designed Study

continual use of opioids after 90 days following surgery

persistent surgical pain after 90 days following surgery

continual use of opioids 30 days after surgery

persistent surgical pain after 30 days following surgery

continual use of opioids 6 months after surgery

persistent surgical pain after 6 months following surgery

total opioid use during the first 3 days following surgery

median pain scores (numeric rating scale) during the first 3 days following surgery

University of California, San Diego

Associate Professor

Soft Tissue Neoplasms

Ropivacaine

Pecs block under real-time ultrasound guidance after anesthesia induction will be performed. In specific, using the in-plane insertion technique, after visualization of the entire needle as a bright hyperechoic line and aiming between pectoralis major and pectoralis minor at the 3rd rib level, 2 ml of normal saline 09% will be injected first, to verify the correct position of the needle. Followingly, 10 mL ropivacaine 0.5% will be injected in order to block the lateral and medial pectoral nerves. Finally, another 15 ml of ropivacaine 0.5% plus 4 mg of dexamethasone will be injected between the pectoralis minor muscle and the anterior serratus muscle,at the level of the 4th and 5th ribs, after negative aspiration, to block the intercostal and intercostobrachial nerves. Using the color Doppler the vessels will be identified, so that their puncture is avoided during the procedures.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Post Mastectomy Pain Syndrome After Preoperative Stellate Ganglion Block for Breast Cancer Surgeries	NCT04238377	Breast Cancer Breast Pain	Stellate Gangli... Multimodal Anal...	18 Years -	National Cancer Institute, Egypt
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
Calming Alternatives Learned During MRI-Guided Breast Biopsy	NCT03877146	Breast Cancer Breast Pain Pain, Acute Anxiety Coping Skills Self Efficacy	Controlled Brea...	18 Years -	Duke University
Symptom Management After Breast Cancer Surgery	NCT00686127	Neuropathic Pai... Postmastectomy ...	Lidoderm patch Placebo patch	18 Years -	University of California, San Francisco
Predicting Chronic Pain Following Breast Surgery	NCT04967352	Chronic Pain Opioid Use Breast Pain Breast Cancer		18 Years -	University of California, San Diego
The Impact of Pecs Blocks on Postmastectomy Pain Syndrome	NCT04586751	Pain Syndrome Pain, Postopera... Chronic Pain Breast Cancer Breast Soft Tis... Breast Neoplasm... Breast Cancer F... Breast Pain Anesthesia	Pecs block no Pecs block	20 Years - 85 Years	Aretaieion University Hospital
Calming Alternatives Learned During MRI-Guided Breast Biopsy	NCT03877146	Breast Cancer Breast Pain Pain, Acute Anxiety Coping Skills Self Efficacy	Controlled Brea...	18 Years -	Duke University
Symptom Management After Breast Cancer Surgery	NCT00686127	Neuropathic Pai... Postmastectomy ...	Lidoderm patch Placebo patch	18 Years -	University of California, San Francisco
Pattern of Clinical Presentation of Different Breast Disease in Surgical Opd at BPKIHS	NCT06026176	Breast Disease Breast Neoplasm... Breast Pain Breast Fibroade...		-	B.P. Koirala Institute of Health Sciences
Calming Alternatives Learned During MRI-Guided Breast Biopsy	NCT03877146	Breast Cancer Breast Pain Pain, Acute Anxiety Coping Skills Self Efficacy	Controlled Brea...	18 Years -	Duke University
Prevention of Post-Mastectomy Breast Pain Using Ambulatory Continuous Paravertebral Blocks	NCT01231204	Paravertebral C... Mastectomy Breast Cancer	Placebo (normal... Ropivicaine 0.4...	18 Years -	University of California, San Diego

Spots Global Cancer Trial Database for breast pain

Every month we try and update this database with for breast pain 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.

Spots Global Cancer Trial Database for breast pain

Every month we try and update this database with for breast pain 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 breast pain 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.