NCT07533279

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

Same day

First QC Date

April 9, 2026

Last Update Submit

April 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Score (VAS)

    Postoperative pain will be assessed using the Visual Analog Scale (VAS) at rest and during movement.

    Within the first 24 hours postoperatively

Secondary Outcomes (3)

  • Total Opioid Consumption

    First 24 hours postoperatively

  • Time to First Analgesic Request

    Within 24 hours postoperatively

  • Postoperative Complications

    Within 24 hours postoperatively

Study Arms (2)

Erector Spinae Plane Block Group

EXPERIMENTAL

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

External Oblique Intercostal Plane Block Group

EXPERIMENTAL

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

Interventions

Bilateral erector spinae plane block will be performed under ultrasound guidance using local anesthetic prior to surgical incision to provide postoperative analgesia.

Erector Spinae Plane Block Group

Bilateral external oblique intercostal plane block will be performed under ultrasound guidance using local anesthetic prior to surgical incision to provide postoperative analgesia.

External Oblique Intercostal Plane Block Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Mohamed Mansour, MD

    Professor of Anesthesia, ICU and Pain Management, Faculty of Medicine, Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Khaled M Hassan mohamed, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The study is double-blinded. The anesthesiologist performing the block is not involved in intraoperative management or postoperative assessment. Patients, intraoperative care providers, and outcome assessors are blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two parallel groups to receive either bilateral erector spinae plane block or bilateral external oblique intercostal plane block.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesia specialist

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 16, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.