NCT07082387

Brief Summary

This study aims to compare the effects of the external oblique and rectus abdominis plane (EXORA) block and the quadratus lumborum block (QLB) on postoperative analgesia in patients undergoing laparoscopic cholecystectomy (LC).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

July 16, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

July 24, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

July 16, 2025

Last Update Submit

April 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to the 1st rescue analgesia

    Time to the first request for the rescue analgesia (time from the end of surgery to first dose of morphine administrated).

    24 hours postoperatively

Secondary Outcomes (4)

  • Total morphine consumption

    24 hours postoperatively

  • Intraoperative fentanyl consumption

    Intraoperatively

  • Degree of pain

    24 hours postoperatively

  • Incidence of adverse events

    24 hours postoperatively

Study Arms (2)

EXORA group

EXPERIMENTAL

Patients will receive an external oblique and rectus abdominis plane (EXORA) block using 20ml of bupivacaine 0.25%.

Other: External oblique and rectus abdominis plane block

QLB group

EXPERIMENTAL

Patients will receive a quadratus lumborum block (QLB) using 20ml of bupivacaine 0.25%.

Other: Quadratus lumborum block

Interventions

Patients will receive an external oblique and rectus abdominis plane (EXORA) block using 20ml of bupivacaine 0.25%.

EXORA group

Patients will receive a quadratus lumborum block (QLB) using 20ml of bupivacaine 0.25%.

QLB group

Eligibility Criteria

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

You may qualify if:

  • Age from 18 to 65 years.
  • Both sexes.
  • American Society of Anesthesiology (ASA) physical status I-II.
  • Undergoing laparoscopic cholecystectomy (LC) under general anesthesia.

You may not qualify if:

  • History of allergies to local anesthetics.
  • Opioid dependency.
  • Bleeding or coagulation disorders.
  • Psychiatric and neurological disorder.
  • Local infection at the site of injection.
  • Body mass index (BMI) \> 35.
  • Hypertension.
  • Uncontrolled diabetes mellitus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

First Submitted

July 16, 2025

First Posted

July 24, 2025

Study Start

July 24, 2025

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations