Erector Spinae Plane Block for Major Gynecologic and Urologic Surgery

Lawson Health Research Institute1 site in 1 country12 target enrollmentSeptember 1, 2019

ConditionsHysterectomy Cystectomy Regional Anesthesia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hysterectomy
Sponsor: Lawson Health Research Institute
Enrollment: 12
Locations: 1
Primary Endpoint: Pain score
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 1, 2019

End Date

August 1, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Lawson Health Research Institute

Responsible Party

Principal Investigator

Kamal Kumar

Associate Professor

Lawson Health Research Institute

Eligibility Criteria

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

•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

Outcomes

Primary Outcomes

Pain score

Time Frame: First 12 postoperative hour

Numeric rating scale (0 - 10) for pain score, area under curve first 12 hours

Opioid consumption

Time Frame: First 12 postoperative hour

Postoperative opioid consumption in oral morphine equivalents

Secondary Outcomes

Opioid consumption 12 - 24 hour(12th to 24th postoperative hour)
Length of stay in hospital(until discharge from hospital, up to 7 days postoperatively)
Number of participants with block related complication(Until discharge, up to 7 days postoperatively)
Pain score 12 - 24 hour(12th to 24th postoperative hour)
Length of stay in post-anesthetic recovery unit(until discharge from post-anesthetic recovery unit, up to 4 hours postoperaively)
Number of participants with opioid related complication(Until discharge, up to 7 days postoperatively)