Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Pain, Postoperative

Pain

Head and Neck Neoplasms

Postoperative Complications

Neurologic Manifestations

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Anesthetics

Ropivacaine

Analgesics, Opioid

Anesthetics, Local

Subjects in the regional anesthesia cohort will have a regional anesthesia block and/or catheter placement administered according to current hospital policies and our established standard of care.

Subjects in the no regional anesthesia cohort will not get pre-operative regional anesthesia, and their surgery and anesthesia will be performed according to normal policies and standard of care in our hospital.

Regional Anesthesia Nerve Block: Incremental injections up to total of 20 mL of 0.5% ropivacaine is administered.

Ropivacaine injection

Rui Fernandes, MD, DMD

Despite many recent advances in pain management, post-operative pain is widely considered to be poorly managed. Furthermore, the mainstay of current pain management is opioids, for which there is strong evidence of ill effects and long-term potential for addiction. There are many studies demonstrating that perineural regional anesthesia can be superior to intravenous opioid analgesia, and that the technique is safe. By using temporary implanted catheters, this method can now deliver prolonged analgesia, thus reducing the need for opioids in the postoperative period. Regional anesthesia is a proven technique and used daily by anesthesiologists, and it is also the first choice for hip and knee replacement surgery for orthopedic surgeons. Patients undergoing head and neck reconstruction with the use of free tissue transfer experience a significant amount of post-operative pain due to the complexity of the surgery, the presence of a head and neck surgical site as well as a secondary donor site, and existing co-morbidities, most commonly malignancy, that also cause significant pain. These patients often require opioids for pain control throughout the hospital stay, and are almost always discharged home with additional opioids. By utilizing regional anesthesia blocks at the donor sites, the investigators can potentially reduce post-operative pain while also reducing the use of opioids.

Regional Anesthesia Block in Fibula Free Flap Reconstruction

Does Regional Anesthesia Reduce Postoperative Opioid Consumption in Subjects Undergoing Fibula Free Flap Reconstruction of the Head and Neck: A Prospective Trial

Defined by the research team as the subjects' morphine equivalent dose at 72 hours (3 days) post-operatively. The postoperative period commences at extubation.

University of Florida

Rare Diseases

Acute Pain

Acute Graft Versus Host Disease

ESPB performed with infusion of Ropivacaine 0,375% (20 ml at ech side)

ESPB performed with infusion of N/S 0,9% (20 ml at each side)

Effect of continuous ESPB performed with Ropivacaine 0,375% infusion, in patients undergoing elective laparoscopic colectomy.

Freideriki Sifaki, M.D., MSc

Pelagia Chloropoulou, PhD

Freideriki Sifaki, MSc

The aim of the trial is to study the efficacy of continuous bilateral Erector Spinae Plane Block (ESPB) in managing perioperative pain in patients who undergo elective laparoscopic colectomy.

Laparoscopic colectomy is a common surgery performed by general surgeons for a variety of reasons, such as colon cancer, inflammatory bowel disease, multiple precancerous colon polyps. Nowadays, due to the evolution of laraposcopic techniques, laparoscopic colectomies are performed with minimally invasive procedures. However, most patients complain for moderate to severe post-operative pain, which requires the application of multimodal analgesia recipes and the administration of large doses of opioids perioperatively, in order to be relieved. Due to the opioid crisis observed in the U.S. and in many european countries and due to the variety of adverse effects observed after the administration of opioids (respiratory depression, nausea, vomiting, delayed mobilization of gastrointestinal system and the patient), which augment not only the hospitalization time but also the hospitilization cost of the patients, anesthesiologists tend to limit their administration, especially in colectomies.

Erector Spinae Plane Block (ESPB) is an innovating trunk block, which was first described in 2016 by Forrero et. al in order to relieve neuropathic pain. Since then, it was embraced by modern anesthesia practices and is currently effectively performed for chronic pain, acute post-traumatic and acute post-operative pain, in various surgical procedures. Specifically, ESPB has been performed for the treatment of thoracic neuropathic pain, of acute post-operative pain after thoracotomy, laparoscopic cholecystectomy, total hip arthroplasty, modified radical mastectomy, emergent laparotomy and after various surgical procedures of the spine, with good results.

There are no clinical trials that study the effectiveness of continuous bilateral Erector Spinae Plane Block in laparoscopic colectomies.

This trial is a randomized, controlled, double - blind, prospective trial, predominantly aiming at evaluating the effectiveness of continuous bilateral Erector Spinae Plane Block (ESPB) in managing perioperative pain in patients who undergo elective laparoscopic colectomy.

This trial will recruit 40 patients (men and women), aged 18 to 85 years old who will undergo laparoscopic colectomy, performed by the same experienced, surgical team.

Patients will be randomized into two groups, Group B (Block Group - Ropivacaine 0,375%) and Group C (Control group - N/S 0,9%).

ESPB will be performed bilaterally, accompanied with the placement of catheters for continuous solution infusion, by the same, experienced in regional anesthesia anesthesiologist, before the induction of general anesthesia. The solutions administered during the performance of ESPB, will be prepared by an independent anesthesiology nurse. The quality of the ultrasound image and the pain intensity during the performance of ESPB, as well as the dermotomes blocked by ESPB and the complications that may arise after the performance of the block, will be recorded.

The age, sex, Body Mass Index and American Society of Anesthesiologists (ASA) classification of the participants, will be recorded. Preoperative standard laboratory tests, as well as TNF-a, Interleukine-1 and Interleukine-6 levels will be recorded.

After the induction of general anesthesia \[propofol (2,5 mg/kg), fentanyl (1 γ/kg), rocuronium (0,6 mg/kg)\], general anesthesia will be maintained with desflurane titration, guided by BIS Monitor readings. In all patients, remifentanil infusion will be titrated in order to achieve intraoperative analgesia, guided by Nociception Monitoring (NOL Monitor). In all patients Magnesium Sulphate 50 mg/kg and Pantoprazole 40 mg will be administered at the start of the surgical procedure. Paracetamol 1000 mg, Tramadol 100 mg, Droperidol 1,25 mg and Ondansetron 4 mg will be also administered to all patients 30 minutes before the end of surgery. During surgery, vital signs, BIS and NOL readings, Cardiac Output, Stroke Volume Variation, Glucose and Lactate levels will be recorded. Total fluids, desflurane and remifentanyl administration, urine output, as well as the administration of other drugs will also be recorded. At the end of surgery, Train of Four stimulation will be performed and in the presence of remaining neuromuscular blockade, sugammadex will be administered in the proper doses.

In all patients, post - operative analgesia will include administration of Paracetamol 1000 mg every 6 hours. Tramadol 50 mg will be offered as rescue analgesia, if NRS pain score of the patient is \> 4. 12, 24, 36 and 48 hours after the performance of ESPB, Ropivacaine 0,375% (patients randomized in Group B) or N/S 0,9% (patients randomized in Group C) will be infused through the ESPB catheters.

The duration of stay of the patient in Post Anesthesia Care Unit (PACU), the Aldrete Score and the vital signs the moment the patient leaves the PACU, will be recorded.

Post - operative observation of the patient will include recording of NRS pain score at rest and activity, Post-Operative Nausea and Vomiting Score, tramadol consumption, vital signs, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the end of surgery. Quality of Recovery Score of the patient will be recorded 72 hours after the end of surgery. Mobilization time of the patient and of the gastrointestinal tract, the time of removal of bladder catheter and drainages, the time of start of oral fluids and enteral nutrition, the discharge time and the total cost, will also be recorded. The satisfaction score of the patient in a scale from 1 to 6, 96 hours after the end of surgery will be recorded. Standard laboratory tests of the first, second and third post-operative days will be recorded, as well as the TNF-a, Interleukine-1 and Interleukine-6 levels the first and the fourth post-operative day.

EFFECT - EFFectiveness of ESPB (Erector Spinae Plane Block) in Laparoscopic Cοlectomies Trial

Effectiveness of Bilateral Erector Spinae Plane Block (ESPB) in Laparoscopic Colectomies -A Randomized, Controlled, Double Blind, Prospective Trial

Quality of Recovery-15 \[(QoR) -15\] Questionnaire. A questionnaire which consists of 15 questions in two Parts, rated from 0 to 10 ("0" is the worst and "10" is the best answer). The worst overall score is 0 and the best overall score is 150.

Time of Mobilization of the gastrointestinal tract and of the patient

Time of start of oral fluids and enteral nutrition

Satisfaction Score of the patient regarding perioperative analgesia, using a numerical rating scale from 1 to 6, where "1" means not satisfied at all and "6" means completely satisfied.

Duration of hospital stay after surgery in days

Pain score at discharge from Post-Anesthesia Care Unit (PACU), ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable", Post Operative Nausea and Vomiting Score at discharge from Post-Anesthesia Care Unit (PACU), ranging from 0 to 2, where "0" means no PONV, "1" means nausea and "2" means vomiting.

Pain score 12 hours post - operatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable", Post Operative Nausea and Vomiting Score 12 hours post - operatively, ranging from 0 to 2, where "0" means no PONV, "1" means nausea and "2" means vomiting.

Pain score 24 hours post - operatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable", Post Operative Nausea and Vomiting Score 24 hours post - operatively, ranging from 0 to 2, where "0" means no PONV, "1" means nausea and "2" means vomiting.

Pain score 36 hours post - operatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable", Post Operative Nausea and Vomiting Score 36 hours post - operatively, ranging from 0 to 2, where "0" means no PONV, "1" means nausea and "2" means vomiting.

Pain score 48 hours post - operatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable", Post Operative Nausea and Vomiting Score 48 hours post - operatively, ranging from 0 to 2, where "0" means no PONV, "1" means nausea and "2" means vomiting.

Total intraoperative Desflurane Consumption

Total intraoperative Remifentanyl Consumption

Total cost of surgery, anesthesia and hospitalization

Comparison of TNF-a, Interleukine-1 and Interleukine-6 levels preoperatively and post - operatively (the first and fourth day after surgery)

Aristotle University Of Thessaloniki

Democritus University of Thrace

M.D., Msc

Skin and Connective Tissue Diseases

Breast Neoplasms

Carcinoma

Carcinoma, Ductal

Carcinoma in Situ

Carcinoma, Intraductal, Noninfiltrating

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Breast Carcinoma In Situ

Antiemetics

Dermatologic Agents

Gastrointestinal Agents

Adjuvants, Anesthesia

Ondansetron

Sufentanil

Dsuvia

Narcotics

Anesthetics, Intravenous

Anesthetics, General

Preoperative Multiple-injection Costotransverse Block (MICB) with three injections of each 10ml of Ropivacaine 5mg/ml corresponding to 3 \* 10ml \* 5mg/ml Ropivacaine = 150mg Ropivacaine.

Preoperative Multiple-injection Costotransverse Block (MICB) with three injections of each 10ml of Sodium chloride 9mg/ml corresponding to 3 \* 10ml \* 9mg/ml Sodium chloride = 189mg Sodium chloride.

Saline 0.9%

30 minutes prior to emergence 0.2 μg/kg total body weight Sufentanil IV and 1 gram of paracetamol IV (if 6hrs since preoperative medicine) and 4 mg ondansetron IV (PONV prophylaxis) will be administered.

Sufentanil and PONV prophylaxis

Jens N Børglum, PhD, MD

The investigators have developed a novel ultrasound-guided nerve block indicated primarily for breast cancer surgery that mimic a thoracic paravertebral block (TPVB) - hitherto the internationally accepted regional anesthesia golden standard for anesthesia of the hemithorax - but hypothetically without the risks of adverse events associated with the TPVB (i.e. pneumothorax, risk of bleeding in the thoracic paravertebral space, random and unmanageable epidural spread etc.). The investigators have already tested the anatomical- and block execution hypothesis in a randomized cadaveric study, and the investigators now have anatomical proof of concept for the functionality of the block technique. The investigators have also conducted a small clinical pilot study with very promising results. The investigators wish to conduct a randomized, placebo controlled and double-blind study, comparing the effect of the ultrasound-guided multiple-injection costotransverse block (MICB) vs. placebo. The aim with this study is to investigate the efficacy of the MICB vs. placebo in patients undergoing unilateral mastectomy and primary reconstructive surgery due to breast cancer or ductal carcinoma in situ. The hypothesis is, that the unilateral MICB will significantly reduce the opioid consumption during the first 24 postoperative hours and significantly reduce the Numerical Rating Scale pain score (0-10) and opioid related side effects.

Twelve women in Denmark are diagnosed with breast cancer every day. Breast cancer and ductal carcinoma in situ (DCIS) are the primary type of cancer/precursor to cancer in women, and one of the main treatment modalities is surgical intervention. DCIS is a non-invasive (pre-malignant) condition in the breast with proliferating cells with malignant characteristics; confined in situ by the basal lamina in the breast. International DCIS is considered as manifest breast cancer, but in Denmark DCIS is considered as a precursor to breast cancer.

Breast cancer and DCIS surgery includes many subtypes ranging from the minor lumpectomy to major surgery; e.g. mastectomy and reconstructive surgery with or without axillary clearance. All surgical subtypes at the Department of Plastic Surgery and Breast Surgery, Zealand University Hospital (ZUH) are performed under general anesthesia (GA) and implies a multimodal pain regimen with preoperative oral medication (Paracetamol 1g, Celecoxib (NSAIDs) 400mg, Gabapentin 600mg, Dexamethasone 8mg and Dextromethorphan 30mg). Standard GA is total intravenous anesthesia (TIVA) and consists of Remifentanil, Propofol (and Rocuronium for tracheal intubation if needed), and the anesthesiologists will administer IV Sufentanil (a synthetic long-lasting opioid) 0.3-0.5 microg/kg 20-30 minutes prior to emergence for the immediate postoperative pain treatment. The patients are given additional Sufentanil and/or morphine intravenously in the post anesthesia care unit (PACU), if necessary.

Depending of surgical subtype, the surgeons will sometimes inject local anesthetic (LA) during surgery. The anesthesiologists will infrequently (depending on the availability of technical skills on the day of surgery) perform ultrasound-guided (USG) nerve blocks (Pecs 1 (and or) 2 and serratus anterior blocks) in the anterolateral thoracic wall prior to surgery, but this is not an implemented standard treatment. It is sadly neither national nor European standard to use USG nerve blocks for perioperative pain management for breast cancer and DCIS surgery. Instead, the vast majority of surgical centers rely heavily on the use of various long-lasting opioids, despite the adverse events associated with these drugs. Only relatively few surgical centers in Europe have implemented TPVB or other USG nerve blocks in the anterior thoracic wall as standard treatment for perioperative pain management.

USG multiple-injection TPVB is considered the regional anesthesia golden standard for breast cancer and DCIS surgery and reduces both acute and chronic pain as well as postoperative opioid consumption.

To determine which surgical subtype would be the most relevant to investigate (define the quantity of the research problem) the research group at ZUH have conducted a thorough retrospective study (including 111 patients) regarding postoperative pain and 12- and 24-hrs opioid consumption concerning patients undergoing breast cancer and DCIS surgery during 2016-2017 at the Department of Plastic Surgery and Breast Surgery, ZUH. The electronic anesthesia files, PACU files and ward files were meticulously reviewed. Six surgical subgroups were reviewed and the UMPR surgery elicited high values on the numeric rating scale (NRS) and a substantial need for perioperative opioids. The survey revealed an overall accumulated morphine consumption in the first 24 postoperative hours of 86.1±60.1mg (mean ± SD) of oral morphine equivalents (OME) and a NRS in the PACU of 4.5±2.4 (mean ± SD) in UMPR patients - and this surgical subtype was selected as most relevant and feasible to investigate. This dosage should be evaluated in relation to the standardized multimodal regimen described above.

There is definitely room for improvement in regards to the current treatment of this patient group. For instance, sub-group analysis reveals that patients having only received our current USG blocks (+preoperative oral medication and GA) have an accumulated morphine consumption in the first 24 postoperative hours of 81±55.2mg (mean ± SD) of OME.

Indication for UMPR surgery is either breast cancer or DCIS. UMPR surgery can be performed in several stages (and with several techniques) involving multiple GA techniques. However, at ZUH one-stage UMPR surgery is common and is described in the following (multiple stage surgery is irrelevant for the study protocol).

Standard operating procedure for one-stage UMPR surgery often involves two surgeons; i.e. one breast surgeon performing the mastectomy and one plastic surgeon performing the subsequent reconstructive surgery.

The mastectomy is skin conserving with incision inferolateral to the breast tissue. The breast tissue is removed leaving a pocket. The area profound to the major pectoral muscle and superficial to the minor pectoral muscle is opened and prepared for a prothesis. Very common this prothesis is an expander-prothesis with a filling-chamber (for subsequent ambulant re-fillings). An expander-prothesis is either permanent or temporary. If permanent the filling-chamber is removed ambulant with LA, if temporary the prothesis is removed in toto under GA and replaced with a permanent prothesis. Two surgical drains are installed; one in the pocket between the major pectoral muscle and the skin and one between the major pectoral muscle and the minor pectoral muscle (beside the prothesis). The drains exit the skin in the lateral thoracic wall without an exact defined anatomical point but often it is in the front axillary line below the incision.

The UMPR patient is evaluated by the operating surgeon around 14 days after surgery where the pathology results are reviewed.

Side effects of the current anesthesiologic practice/treatment. The use of morphine (IV and oral) can cause severe side effects, including nausea and vomiting, bowl paralysis, urine retention, sleep disturbances and respiratory depression. These side effects can delay mobilization after surgery, increase the risk of complications and worst of all be fatal.

In addition to all the well-known adverse events associated with morphine and the synthetic opioid derivate, these drugs have several masked adverse events (e.g. immunomodulation, hormonal disturbing, delirium triggering, angiogenetic etc.). Despite numerous (retrospective) studies regarding these issues, it is not yet possible to definitively link morphine consumption to metastasis formation and subsequent cancer recurrence. However, the surgical stress during the surgical procedures possibly generates an advantageous environment for dissemination of tumor cells when these inevitably are released to the blood stream by surgery. Studies advocate that TPVB reduces the perioperative opioid consumption - an indication of reduced surgical stress and other studies indicate that TPVB might even decrease the metastasis and progression of breast cancer. Large prospective studies regarding breast cancer recurrence with TPVB (and thoracic epidurals) are still ongoing.

Chronic postoperative pain Chronic postoperative pain (CPP) is a significant and very common problem associated to breast cancer and DCIS surgery ranging between 20-65% in all patients. Moderate to severe pain is reported to be between 10-20%. The underlying etiology is multifactorial and not fully understood, but it is suggested that CPP is occurring from a perioperative sensitization of the central nervous system. Numerous studies suggest that TPVB might decrease CPP and it has been postulated that the effect is due to an efficient treatment of acute pain leading to a decreased sensitization (both peripheral and central sensory) and a lower incidence of CPP.

A new prospective observational study finds that severity of acute pain is associated with the development of persistent pain.

The new block. The breast is innervated by the lateral and medial pectoral nerves from the brachial plexus and the T2-T6 thoracic spinal nerves. Hence, no regional technique will block the entire hemithorax with a single injection. The relatively new USG nerve blocks in the anterior thoracic wall like the "pecs block" and serratus anterior plane block, do not target the same nerves as TPVB.

The TPVB is executed in the posterior thoracic wall near the vertebral bodies with the needle tip just adjacent to the pleura and thereby with an inherent risk of pneumothorax as well as other serious adverse events. In expert hands and with ultrasound guidance the risk is probably relatively low. However, many anesthesiologists are still reluctant to perform the block due to the perceived risks.

Recently, the erector spinae plane block (ESPB) emerged and quickly gained a lot of attention for various indications. The ESPB have only been used for breast cancer surgery in a few case studies and in one RCT but presumably with some success.

The investigators have modified the ESPB to a novel multiple-injection costotransverse block (MICB). MICB is also a USG nerve block in the posterior thoracic wall. With MICB, the investigators inject LA on the superficial side of the superior costotransverse ligament (SCTL); which is the posterior border of the thoracic paravertebral space (TPVS). The LA will spread from the injection point and into the TPVS via the costotransverse foramen and the veins traversing the SCTL. Thereby the investigators mimic a TPVB, but - very important - with the needle tip in a very comfortable distance to the pleura reducing the risk of adverse events. The investigators have already proved this in a large cadaveric study with multinational collaboration. In this study, the MICB effectively stained the ventral rami, the communicating rami and the thoracic sympathetic trunk. Epidural spread was completely absent with the MICB.

The investigators have published two abstracts concerning this new block modality - and the main article is published in Acta Anaesthesiologica Scandinavica.

Pilot studies show that the MICB is considered a PNB with very little discomfort for the patient (NRS 1-2) "as painful as having a standard IV line in the hand" - which aligns with a previous study performed in our department regarding a deep nerve block for analgesia of the abdominal wall.

As the end-point for the MICB is the analgesic effect of a TPVB the investigators find it relevant to describe the contraindications to TPVB.

In general, there are few contraindications to TPVB. However, infection at the site of needle insertion, empyema, allergy to local anesthetic drugs, patient refusal and tumor occupying the TPVS are the most common noted contraindications in the literature. Before the emergence of ultrasound for nerve block execution coagulopathy, bleeding disorder or therapeutic anticoagulation were considered as relative contraindications for TPVB. Today, with ultrasound guidance there are no firm consensus on relative contraindications regarding especially therapeutic anticoagulation when performing TPVB.

Every day the investigators perform deep truncal blocks at the department at ZUH and the investigators have yet to see bleeding as a complication. The MICB is NOT a neuraxial block, neither do the investigators consider it a deep block. The mere purpose of the MICB is to further reduce the already low incidence of complications with TPVB. Recently, one accidental pneumothorax (with TPVB) was reported in well over 2000 patients, but not a single bleeding complication was reported and another study with 1427 TPVBs only six complications was reported (no bleeding); all handled successfully.

The investigators generally consider the MICB (and other paravertebral blocks by proxy) as safe procedures.

The Ultrasound-guided Multiple-injection Costotransverse Block for Mastectomy and Primary Reconstructive Surgery.

The Ultrasound-guided Multiple-injection Costotransverse Block for Mastectomy and Primary Reconstructive Surgery. A Double Blind, Randomised, Placebo Controlled Trial.

The primary aim of this study is total morphine consumption in the first 24 postoperative hours (data from PCA pump and the patient's medical record).

Pain intensity (NRS 0-10/10) in the study period at T0 (arrival in the PACU), after 15 minutes, 30 minutes, 45 minutes and one hour.

And pain intensity (NRS 0-10/10) in the intervals

* \[ arrival at the ward - 4 hrs. postop \]
* \] 4 hrs. postop - 8 hrs. postop \]
* \] 8 hrs. postop - 12 hrs. postop \]
* \] 12 hrs. postop - 16 hrs. postop \]
* \] 16 hrs. postop - 20 hrs. postop \]
* \] 20 hrs. postop - 24 hrs. postop \]

NRS score will be recorded electronically in the PCA-pump when morphine is administrated. All patients must enter NRS 0-10 on the PCA pump prior to morphine bolus administration.

Patient is asked immediately after block application, Numeric Rating Scale (0-10, 0 = no pain, 10 = worst pain)

PONV. 0-3; 0=No nausea. 3=Unmanageable nausea

When is the patient capable to ambulate; ie. going to the bathroom by themself

Quality of Recovery - 15 score (QoR15). Preoperatively compared to twice postoperatively. Preoperatively the patients are asked to fill in the validated Quality of Recovery Questionnaire QoR1536 questionnaire repeated at T0+24hrs. and 14 days after surgery (possibly by phone interview). The QoR15 questionnaire results in a score of 0-150.

Copenhagen University Hospital, Denmark

Zealand University Hospital

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma, Renal Cell

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Anti-Arrhythmia Agents

Channel Blockers

Vasoconstrictor Agents

Respiratory System Agents

Lidocaine

Epinephrine

Racepinephrine

Epinephryl borate

A high-frequency linear ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to the T7/T8 spinous process. The patient's skin will be anesthetized with 2% lidocaine. A Contiplex Echo ultra 360 18G needle with 20G × 55 cm Contiplex Echo catheter will be inserted using an in-plane superior-to-inferior approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process. A total of 30 mL of 0.375% ropivacaine with 5mcg/mL of epinephrine will be injected in 5-mL aliquots through the needle (maximum of 3mg/kg) followed by insertion of the echo catheter system under direct vision 2-3 cm beyond the needle tip.

The exact same procedure as the experimental group will be followed, substituting saline for local anesthetic at the same amounts and rate. As with the ESP group, the patients will have PCA initiated postoperatively in the PACU at the same doses.

30ml of 0.375% ropivacaine with 5mcg/ml of epinephrine will be injected into the fascial plane on the anterior spinae muscle.

Saline will be used at the same amounts as the ropivacaine arm.

Sham

Shahid Lambe, MD

Peter Moisiuk, MD

Aaron Kugler, MD

Nephrectomy (kidney removal) is one of the most common surgical procedures in urologic practice. Recent advances in laparoscopic (keyhole) procedures have resulted in a significant decrease in open nephrectomies. Most laparoscopic surgeries are performed through 3 to 4 small (1 to 1.5 cm) incisions; however, laparoscopic nephrectomies for cancer include one of the incisions being extended to 7 to 10 cm for kidney removal. Although pain after laparoscopic surgery is somewhat less than that after open surgery, it is still significant, and opioid consumption is similar. Opioids have been a mainstay for the treatment of post-operative pain, but they are associated with many adverse effects and a potential for long-term use. Thus, combining opioid analgesia with other forms of analgesia has the potential to reduce opioid use. Paravertebral nerve blocks, where local anesthetic is injected near the spinal nerves, have recently shown good pain control in patients undergoing thoracic and abdominal surgeries. However, this technique is technically challenging, time consuming, and has the risk of significant side effects. Fascial plane blocks are an alternative to paravertebral blocks. Fascial plane blocks, where local anesthetic is injected in areas further away from the spinal nerves, are easier to perform than paravertebral blocks, and have fewer associated risks. A recently described fascial plane block, the Erector Spinae Plane (ESP) block, has been shown to be effective in controlling pain in a variety of surgeries. However, currently, there is little information regarding its use in laparoscopic nephrectomy. We are proposing this pilot randomized control trial to look at the feasibility of completing a larger randomized control trial to evaluate ESP blockade in patients undergoing laparoscopic nephrectomy for cancer. We will also investigate total opioid consumption, and pain scores at rest and during movement.

While post-operative pain seems to be slightly decreased compared to open nephrectomies, pain from laparoscopic nephrectomy is still significant and opioid consumption is similar.Adequate management of post-operative pain is imperative in early post-operative mobilization. ¬Although opioids have been a mainstay for the treatment of post-operative pain, other strategies should be considered as opioids are associated with adverse effects, the potential for long-term opioid use, and even death. There have been an increasing number of opioid related deaths with 2,066 apparent opioid-related deaths in Canada over the first half of 2018. With the need to address the worsening opioid crisis, it is essential that other non-opioid strategies are explored and considered. Multimodal anesthesia has been one effort to reduce opioid use post-operatively. Increasingly, the literature shows that peripheral nerve blocks reduce post-operative opioid consumption in a vast variety of surgeries.

Traditionally patients undergoing laparoscopic nephrectomy have opioid patient controlled analgesia pumps (PCAs) for post-operative pain control. PCA is widely recognized as an effective technique after laparoscopic nephrectomy to reduce pain scores. A meta-analysis of 49 articles showed PCA had better postoperative pain control than nurse administered analgesics over most time intervals with higher patient satisfaction. Complications of a PCA include respiratory depression, confusion or sedation, nausea, pruritus, ileus, and insufficient analgesia. Paravertebral blocks (PVB) have recently showed promise and increasing clinical uptake due to a growing use of ultrasound-guided regional anesthesia. They provide good pain control in patients undergoing thoracic and abdominal surgeries. In PVB, local anesthetic is injected near the thoracic spinal nerve at its exit from the intervertebral foramina, which results in unilateral somatic and sympathetic nerve blockade in multiple continuous thoracic dermatomes above and below the site of injection. However, this technique is technically challenging, time consuming, and carries a risk of pneumothorax. Fascial plane blocks are increasingly used as an alternative regional anesthetic strategy for abdominal surgery.

Recently ultrasound-guided Erector Spinae Plane (ESP) block was described in which local anesthetic is injected around the erector spinae muscle which tends to block the dorsal and ventral rami of the thoracic spinal nerves. There is growing evidence of its use in a wide range of surgeries. The appeal of the ESP block is in providing analgesia without the potential for needle pleura interaction and the consequent risk of pneumothorax. This interfascial block involves ultrasound guided injection of local anesthetics under the erector spinae muscle and superficial to transverse process of thoracic vertebrae at appropriate level. The ESP block targets the dorsal and ventral rami of the spinal nerves as they leave the intervertebral foramen. Cadaveric examination of ESP block showed extensive cranial-caudal spread of the block, approximately four dermatomes above and below the site of injection. The fact that the site of injection is distant from the spinal cord and pleura, increases the safety of the ESP block as compared to a paravertebral block. The transverse process is easily visualized on ultrasound and acts as a backstop for the needle, preventing excessively deep placement. Of importance, a catheter can also be placed easily during the ESP block allowing continuous infusion and prolonged analgesia. Given the importance of providing adequate analgesia in patients undergoing laparoscopic nephrectomy and the lack of consensus amongst surgeons and anesthesiologists for the optimal analgesic technique, we are proposing a pilot randomized controlled trial (RCT) to determine the feasibility of a larger RCT to compare continuous ESP blockade vs a Sham blockade. Both groups will receive opioid PCA and other multimodal analgesia combined with opioid PCA versus opioid PCA alone.

Literature review: We conducted a review via Pubmed looking at all studies associated with "erector spinae block". Of the studies found, 123 relevant studies were reviewed. The studies included 92 case reports and 4 randomized control trials, with the others being anatomical reviews, editorials, or small review articles. Of these, there were only 4 patients from 1 case series article where patients received ESP blocks for laparoscopic nephrectomies. None of these patients required post-operative opioids in addition to their ESP block infusions. We also reviewed clinicaltrials.gov for ongoing and proposed trials related to the ESP block. Currently, we identified 51 studies involving the ESP block. The vast majority of these revolved around thoracic and general surgery, including some randomized controlled trials. There was only 1 proposed trial studying the use of the ESP block with nephrectomies, but this one was evaluating surgeries

Research Pharmacy will provide randomization/allocation.

ESP Block for Laparoscopic Nephrectomy Surgeries

The Benefit of Adding Ultrasound-guided ESP Block to PCA vs. PCA Alone for Postoperative Analgesia After Laparoscopic Nephrectomy Surgeries: a Pilot, Randomized Controlled Trial

Total long acting opioid consumption in hydromorphone equivalents

Pain scores will be recorded at intervals. The Numerical Rating Scale (NRS) is an 11-point scale where 0 is no pain and 10 is the worst pain imaginable.

Incidence of postoperative nausea-vomiting; respiratory depression; itching; local anesthetic toxicity; catheter leakage and catheter migration; infection at catheter site

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Regional Anesthesia Block in Fibula Free Flap Reconstruction	NCT03906838	Anesthesia, Loc... Surgery Opioid Use Pain, Postopera... Head and Neck N...	Ropivacaine inj...	18 Years - 100 Years	University of Florida
Regional Anesthesia Block in Fibula Free Flap Reconstruction	NCT03906838	Anesthesia, Loc... Surgery Opioid Use Pain, Postopera... Head and Neck N...	Ropivacaine inj...	18 Years - 100 Years	University of Florida
EFFECT - EFFectiveness of ESPB (Erector Spinae Plane Block) in Laparoscopic Cοlectomies Trial	NCT04879004	Pain, Postopera... Acute Pain Postoperative C... Pain Ropivacaine Analgesia Regional Anesth... Analgesics Anesthesia, Loc... Colorectal Canc... Perioperative P...	Ropivacaine inj...	18 Years - 85 Years	Democritus University of Thrace
The Ultrasound-guided Multiple-injection Costotransverse Block for Mastectomy and Primary Reconstructive Surgery.	NCT04248179	Breast Cancer Ductal Carcinom...	Ropivacaine inj... Saline 0.9% Sufentanil and ...	18 Years -	Zealand University Hospital
EFFECT - EFFectiveness of ESPB (Erector Spinae Plane Block) in Laparoscopic Cοlectomies Trial	NCT04879004	Pain, Postopera... Acute Pain Postoperative C... Pain Ropivacaine Analgesia Regional Anesth... Analgesics Anesthesia, Loc... Colorectal Canc... Perioperative P...	Ropivacaine inj...	18 Years - 85 Years	Democritus University of Thrace
EFFECT - EFFectiveness of ESPB (Erector Spinae Plane Block) in Laparoscopic Cοlectomies Trial	NCT04879004	Pain, Postopera... Acute Pain Postoperative C... Pain Ropivacaine Analgesia Regional Anesth... Analgesics Anesthesia, Loc... Colorectal Canc... Perioperative P...	Ropivacaine inj...	18 Years - 85 Years	Democritus University of Thrace
Regional Anesthesia Block in Fibula Free Flap Reconstruction	NCT03906838	Anesthesia, Loc... Surgery Opioid Use Pain, Postopera... Head and Neck N...	Ropivacaine inj...	18 Years - 100 Years	University of Florida
ESP Block for Laparoscopic Nephrectomy Surgeries	NCT04085237	Kidney Cancer Post-surgical P...	Ropivacaine inj... Sham	18 Years -	McMaster University
EFFECT - EFFectiveness of ESPB (Erector Spinae Plane Block) in Laparoscopic Cοlectomies Trial	NCT04879004	Pain, Postopera... Acute Pain Postoperative C... Pain Ropivacaine Analgesia Regional Anesth... Analgesics Anesthesia, Loc... Colorectal Canc... Perioperative P...	Ropivacaine inj...	18 Years - 85 Years	Democritus University of Thrace

Spots Global Cancer Trial Database for ropivacaine injection