Erector Spinae Plane Block for Major Gynecologic and Urologic Surgery

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.

Study Overview

• Status: Terminated
• Conditions: Hysterectomy; Regional Anesthesia; Cystectomy
• Intervention / Treatment: Procedure: Erector spinae plane block; Procedure: Sham block

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, n6c6a7
      • Cheng Lin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Erector spinae plane block; Ropivacaine 0.5% 20 mL at each site of ESPB
Sham Comparator: Shame 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.	Procedure: Sham block; Skin infiltration only

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Cheng Lin, Western University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: March 17, 2018
• First Submitted That Met QC Criteria: April 15, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 111510

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No