Erector Spinae Plane Block for Major Gynecologic and Urologic Surgery

Not Applicable

Terminated

• Conditions: Cystectomy; Hysterectomy; Regional Anesthesia

• 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

Study Timeline

• Study First Submitted: 2018-03-17
• Study First Submitted QC: 2018-04-15
• Study First Posted: 2018-04-18
• Study Start: 2019-09-01
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

1. BMI > 40
2. Non-English speaking
3. Patient refusal or inability to consent
4. Cognitive or psychiatric history that would make it difficult to assess pain score
5. Pre-existing chronic pain condition
6. Preoperative opioid use greater than the equivalent of oral morphine 30 mg daily
7. Infection over site of block placement
8. Allergy or contraindication to any study medication
9. Coagulopathy or thrombocytopenia
10. Postoperative ICU admission
11. Presence of significant cardiac, respiratory, hepatic, renal or neurologic diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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