Erector Spinae Plane Block Versus External Oblique Intercostal Plane Block for Analgesia in Open Cholecystectomy

April 9, 2026 updated by: Salaheldin Ahmed Abdelziz, Sohag University

Efficacy of Bilateral Erector Spinae Plane Block Versus Bilateral External Oblique Intercostal Plane Block for Perioperative Analgesia in Open Cholecystectomy Surgeries: A Randomized Controlled Trial

This randomized controlled trial aims to compare the analgesic efficacy of bilateral ultrasound-guided erector spinae plane block (ESPB) versus bilateral external oblique intercostal plane (EOI) block in patients undergoing open cholecystectomy.

Patients will be randomly allocated into two groups to receive either ESPB or EOI block in addition to standard general anesthesia. The primary outcome is postoperative pain score assessed using the Numerical Rating Scale (NRS) at 2 hours after surgery. Secondary outcomes include intraoperative opioid consumption, postoperative nalbuphine requirements, time to first analgesic request, and hemodynamic changes.

This study seeks to determine the more effective regional anesthesia technique for improving perioperative analgesia in open cholecystectomy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Open cholecystectomy is still indicated in selected patients such as those with complicated gallbladder disease or contraindications to laparoscopy. Effective perioperative pain management is essential to improve patient outcomes and reduce opioid consumption.

Regional anesthesia techniques have gained increasing interest, particularly with the use of ultrasound guidance. The erector spinae plane block (ESPB) is a relatively simple and widely used interfascial block that provides effective analgesia for abdominal surgeries. The external oblique intercostal plane (EOI) block is a newer technique targeting the upper abdominal wall.

In this prospective, randomized, double-blinded clinical trial, adult patients undergoing elective open cholecystectomy will be randomized into two groups. One group will receive bilateral ultrasound-guided ESPB, while the other group will receive bilateral ultrasound-guided EOI block, both performed after induction of general anesthesia and before surgical incision.

All patients will receive standardized general anesthesia. Pain will be assessed using the Numerical Rating Scale (NRS) at multiple time points postoperatively. Rescue analgesia with intravenous nalbuphine will be administered as needed.

The primary outcome is postoperative pain score at 2 hours. Secondary outcomes include intraoperative fentanyl consumption, total nalbuphine consumption over 24 hours, time to first analgesic request, hemodynamic parameters, and any block-related complications.

This study aims to provide evidence regarding the comparative effectiveness of ESPB and EOI block in open cholecystectomy surgeries.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients aged 18-65 years.
  • Patients scheduled for elective open cholecystectomy.
  • American Society of Anesthesiologists (ASA) physical status I-II.
  • Patients who provide informed consent.

Exclusion Criteria:

  • Patient refusal.
  • Known allergy to local anesthetics.
  • Coagulopathy or anticoagulant therapy.
  • Infection at the site of injection.
  • Severe hepatic, renal, or cardiac disease.
  • Body mass index (BMI) > 35 kg/m².
  • Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erector Spinae Plane Block Group
Participants in this group will receive bilateral erector spinae plane block using local anesthetic for postoperative analgesia following open cholecystectomy.
Procedure: Erector Spinae Plane Block
Bilateral erector spinae plane block will be performed under ultrasound guidance using local anesthetic prior to surgical incision to provide postoperative analgesia.
Experimental: External Oblique Intercostal Plane Block Group
Participants in this group will receive bilateral external oblique intercostal plane block using local anesthetic for postoperative analgesia following open cholecystectomy.
Procedure: External Oblique Intercostal Plane Block
Bilateral external oblique intercostal plane block will be performed under ultrasound guidance using local anesthetic prior to surgical incision to provide postoperative analgesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Score (VAS)
Time Frame: Within the first 24 hours postoperatively
Postoperative pain will be assessed using the Visual Analog Scale (VAS) at rest and during movement.
Within the first 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Opioid Consumption
Time Frame: First 24 hours postoperatively
Total opioid consumption in the first 24 hours after surgery measured in morphine equivalents.
First 24 hours postoperatively
Time to First Analgesic Request
Time Frame: Within 24 hours postoperatively
Time elapsed from the end of surgery to the first request for analgesia.
Within 24 hours postoperatively
Postoperative Complications
Time Frame: Within 24 hours postoperatively
Incidence of postoperative complications including nausea, vomiting, and respiratory complications.
Within 24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Collaborators

Cairo University

Investigators

  • Principal Investigator: Mohamed Mansour, MD, Professor of Anesthesia, ICU and Pain Management, Faculty of Medicine, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD-37-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared. The study investigators do not plan to make individual-level data publicly available. Results will be reported in aggregate form to ensure participant confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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