Erector Spinae Plane Block for Major Gynecologic and Urologic Surgery
- Conditions
- CystectomyHysterectomyRegional Anesthesia
- Interventions
- Procedure: Erector spinae plane blockProcedure: Sham block
- Registration Number
- NCT03500744
- Lead Sponsor
- Lawson Health Research Institute
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 12
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Erector spinae plane block Erector spinae plane block 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. Shame block Sham block 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.
- Primary Outcome Measures
Name Time Method Pain score First 12 postoperative hour Numeric rating scale (0 - 10) for pain score, area under curve first 12 hours
Opioid consumption First 12 postoperative hour Postoperative opioid consumption in oral morphine equivalents
- Secondary Outcome Measures
Name Time Method Opioid consumption 12 - 24 hour 12th to 24th postoperative hour Postoperative opioid consumption in oral morphine equivalents
Length of stay in hospital until discharge from hospital, up to 7 days postoperatively Length of stay in hospital
Number of participants with block related complication Until discharge, up to 7 days postoperatively Hematoma, nerve deficit, pneumothorax
Pain score 12 - 24 hour 12th to 24th postoperative hour Area under curve of Numeric rating scale(0 - 10) pain score during the 12 to 24th postoperative hour
Length of stay in post-anesthetic recovery unit until discharge from post-anesthetic recovery unit, up to 4 hours postoperaively Length of stay in post-anesthetic recovery unit
Number of participants with opioid related complication Until discharge, up to 7 days postoperatively Nausea, vomiting, pruritus
Trial Locations
- Locations (1)
Cheng Lin
🇨🇦London, Ontario, Canada