Erector Spinae Plane Block for Major Gynecologic and Urologic Surgery

NCT03500744 | Terminated

• 1 other identifier: 111510
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Hysterectomy; Cystectomy; Regional Anesthesia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

  until discharge from hospital, up to 7 days postoperatively

• Number of participants with opioid related complication

  Until discharge, 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

Study Arms (2)

Erector spinae plane block

EXPERIMENTAL

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

Shame block

SHAM COMPARATOR

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

Interventions

Erector spinae plane block PROCEDURE

Ropivacaine 0.5% 20 mL at each site of ESPB

Erector spinae plane block

Sham block PROCEDURE

Skin infiltration only

Shame block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Cheng Lin

London, Ontario, n6c6a7, Canada

Location

Study Officials

• Cheng Lin

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Sham block will be performed
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 17, 2018
• First Posted: April 18, 2018
• Study Start: September 1, 2019
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: October 5, 2023

Record last verified: 2023-10

Locations

CA (1)