Efficacy of Erector Spinae Plane (ESP) Block in Patients With Inflammatory Bowel Disease (IBD)

NCT06230003 | Completed

• 1 other identifier: 20-0272-A
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a prospective, double-blind randomized controlled clinical trial. There will be two arms of treatment: intervention and control group. Preoperatively patients will be allocated at random to receive ultrasound guided bilateral ESP block either with the local anesthetic (intervention group) normal saline (control group). The aim of this study is to examine the effect of ESP block to increase the Quality of Recovery (measured via QoR-15 total score) and decrease opioid consumption.

Conditions

Opioid Use

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery (via QoR-15) total score

  This will be measured via QoR-15 (Quality of Recovery-15 questionnaire) where, "0" means the worst and "15" the best outcome.

  baseline, 24 hours, 48 hours and 72 hours postoperatively

Secondary Outcomes (4)

• The intensity of postoperative pain

  baseline, 24 hours, 48 hours and 72 hours postoperatively

• Opioid consumption

  24 hours, 48 hours and 72 hours postoperatively

• Opioid related side effects

  baseline, 24 hours, 48 hours and 72 hours postoperatively

• The hospital LOS

  From admission to the hospital until discharge, an average of 5 days

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Ultrasound guided bilateral ESP block either with local anesthetic

Drug: Ropivacaine

Control group

PLACEBO COMPARATOR

Ultrasound guided bilateral ESP block either with normal saline

Drug: normal saline

Interventions

Ropivacaine DRUG

Ultrasound guided ESP block either with the local anesthetic of 0.5% of Ropivicane 20 mL bilaterally (intervention group) or normal saline (control group) before surgery which will take 5-10 minutes in a 1:1 ratio.

Intervention group

normal saline DRUG

Ultrasound guided bilateral ESP block either with normal saline

Control group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18-85 years old) diagnosed with IBD
• ASA physical status I-III
• IBD abdominal laparoscopic assisted surgeries under general anesthesia

You may not qualify if:

• Unable to communicate in English
• Unstable requiring emergency surgery
• Open laparotomies
• Morbidly obese
• Pregnant
• On chronic opioid treatment
• Known allergies to local anesthetics
• Altered mental status
• Concomitant injuries.

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, Canada

Location

MeSH Terms

Interventions

Ropivacaine; Saline Solution

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Naveed Siddiqui, MD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: January 29, 2024
• Study Start: July 21, 2021
• Primary Completion: December 17, 2024
• Study Completion: March 1, 2025
• Last Updated: May 8, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)