Erector Spinae Plane Block for Major Gynecologic and Urologic Surgery

Study Overview
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Brief Summary
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Regional anesthesia, also know as a nerve block, is a key component of pain control after major abdominal surgery. Bilateral erector spinae plane block (ESPB) performed at low thoracic level has been shown to be an effective pain control method in case reports. This pilot study aims to further characterize the pain-control characteristics and to provide baseline data for future trials.

Official Title
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Erector Spinae Plane Block for Major Gynecologic and Urologic Surgery

Conditions
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Hysterectomy, Cystectomy, Regional Anesthesia

Intervention / Treatment
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* Procedure: Erector spinae plane block
* Procedure: Sham block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult surgical patients who are American Society of Anesthesiologists (ASA) class I to III, undergoing cystectomy, or total abdominal hysterectomy, salpingo-oophrectomy with or without omentectomy via midline laparotomy. Exclusion Criteria: BMI > 40 Non-English speaking Patient refusal or inability to consent Cognitive or psychiatric history that would make it difficult to assess pain score Pre-existing chronic pain condition Preoperative opioid use greater than the equivalent of oral morphine 30 mg daily Infection over site of block placement Allergy or contraindication to any study medication Coagulopathy or thrombocytopenia Postoperative ICU admission Presence of significant cardiac, respiratory, hepatic, renal or neurologic diseases

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erector spinae plane block<br>The ESPB will be performed with ultrasound guidance. After identifying a suitable location between 8th and 10th thoracic spine transverse process, the overlying skin will be infiltrated with local anesthetic. A 22 gauge 90-mm needle will be inserted to make contact with the transverse process and withdraw slightly. Ropivacaine 0.5% 20 mL will be injected at this location. The same procedure will be performed on the other side. Additionally, patients will receive acetaminophen, gabapentin and intravenous patient-controlled analgesia opioids. | Procedure: Erector spinae plane block<br>* Ropivacaine 0.5% 20 mL at each site of ESPB<br>|
| Sham Comparator: Shame block<br>A sham block will be performed by performing ultrasound examination of the back looking for intended location for ESPB placement. Skin will be infiltrated with local anesthetics but ESPB will not be performed. Additionally, patients will receive acetaminophen, gabapentin and intravenous patient-controlled analgesia opioids. | Procedure: Sham block<br>* Skin infiltration only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | Postoperative opioid consumption in oral morphine equivalents | First 12 postoperative hour | 
| Pain score | Numeric rating scale (0 - 10) for pain score, area under curve first 12 hours | First 12 postoperative hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in post-anesthetic recovery unit | Length of stay in post-anesthetic recovery unit | until discharge from post-anesthetic recovery unit, up to 4 hours postoperaively | 
| Length of stay in hospital | Length of stay in hospital | until discharge from hospital, up to 7 days postoperatively | 
| Number of participants with opioid related complication | Nausea, vomiting, pruritus | Until discharge, up to 7 days postoperatively | 
| Number of participants with block related complication | Hematoma, nerve deficit, pneumothorax | Until discharge, up to 7 days postoperatively | 
| Pain score 12 - 24 hour | Area under curve of Numeric rating scale(0 - 10) pain score during the 12 to 24th postoperative hour | 12th to 24th postoperative hour | 
| Opioid consumption 12 - 24 hour | Postoperative opioid consumption in oral morphine equivalents | 12th to 24th postoperative hour |