Adding Magnesium Sulfate or Dexmedetomidine to Bupivacaine in Oblique Subcostal Tap Block for Laparoscopic Cholecystectomy: A Randomized Double -Blind Controlled Study

March 31, 2026 updated by: Khaled Zaki Mousa Sayed Mansour, Assiut University

Laparoscopic cholecystectomy (LC) is one of the commonly performed surgical procedures associated with a moderate degree of postoperative pain especially on the 1st postoperative day. Adequate postoperative analgesia allows early patient ambulation, decreases analgesic requirements, and hospital stay. Moreover, it has been hypothesized that intense acute pain after LC may predict development of chronic pain (e.g., post laparoscopic cholecystectomy syndrome). So, aggressive perioperative analgesia is needed.

the aim of the study is To compare the analgesic effect of magnesium sulfate combined with bupivacaine versus bupivacaine combined dexmedetomidine via OSCTAB block on postoperative pain control for 24 hours in patients scheduled for LC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Transversus abdominis plane (TAP) block is a recent analgesic technique with efficacy in perioperative pain therapy for LC. It involves the infusion of local anesthetic into the fascial plane of the abdominal wall.

Oblique subcostal transversus abdominis plane (OSCTAP) block is an US-guided regional anesthesia technique that anesthetizes the nerves of the lower and upper anterior abdominal wall, specifically from T6 to L1. There weren't enough studies in the literature evaluating the OSCTAP block for pain management after LC.

Rafi et al and McDonnell et al were first to describe this novel abdominal field block. They described an anatomical landmark technique and provided evidence of blockade to the mid/lower thoracic and upper lumbar spinal nerves as they travelled in the fascial plane between the transversus abdominis (TA) and internal oblique (IO) muscles.

The OSCTAB block provides more effective analgesia than other TAP blocks. Numerous regional anesthetic adjuvants.

such as dexmedetomidine, clonidine, epinephrine, dexamethasone, and magnesium sulphate (MgSO4) are usually combined with enhancement of analgesic efficacy.

Recently, these adjuvants added to LA solution for prolonging the effect of TAP block with promising results.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Egypt
    • Asyut Governorate
      • Asyut, Asyut Governorate, Egypt, 2067011
        • Assiut University Hospitals

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • Patients programmed for elective LC.

    • American society of anesthesiologists (ASA) physical state I or II.
    • Age over 18 years and less than 60 years old.
    • Patients of both sex are included in the study.

Exclusion Criteria:

  • •Patient refusal

    • Known hypersensitivity to the study drugs.
    • Body Mass Index > 40 kg/m2.
    • Inability to accurately describe postoperative pain to investigators.
    • Opioid tolerance or dependence.
    • Preexisting history of chronic pain.
    • History of renal, liver, cardiac, neuropsychiatric disorder problems.
    • Bleeding or coagulation abnormality.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group 1
patient will receive 20 ml bupivacaine 0.25% plus 500 mg magnesium sulfate in 5ml normal saline on both sides.
Drug: Magnesium sulfate 50% - 1g/h
magnesium sulfate group 20 ml bupivacaine 0.25% plus 500 mg magnesium sulfate in 5ml normal saline on both sides.
Drug: Bupivacaine
20 ml bupivacaine 0.25% plus 5 ml normal saline on both sides.
Experimental: group 2
patients will receive 20 ml bupivacaine 0.25% plus o .5 microg per kg dexmedetomidine in 5 ml normal saline on both sides.
Drug: Bupivacaine
20 ml bupivacaine 0.25% plus 5 ml normal saline on both sides.
Drug: dexmedetomidine 0.5 µg/kg IV
dexmedetomidine group 20 ml bupivacaine 0.25% plus o .5 microg per kg dexmedetomidine in 5 ml normal saline on both sides.
Placebo Comparator: group 3
patients will receive 20 ml bupivacaine 0.25% plus 5 ml normal saline on both sides.
Drug: Bupivacaine
20 ml bupivacaine 0.25% plus 5 ml normal saline on both sides.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post operative ( NRS score
Time Frame: 24 hours
analgesic effect of OSCTAB block on postoperative pain control according to (NRS) for 24 hours in patients scheduled for LC.
24 hours

Collaborators and Investigators

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

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 1, 2025

Primary Completion (Actual)

January 1, 2026

Study Completion (Actual)

March 1, 2026

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

December 17, 2024

First Posted (Actual)

December 20, 2024

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSCTAP Cholecystectomy

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

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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.

Clinical Trials on Laparoscopic Cholecystectomy

Clinical Trials on Magnesium sulfate 50% - 1g/h

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe