Effect of Transversus Abdominis Plane (TAP) Block Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post Operative Pain Following Open Abdominal Cancer Surgery.

November 4, 2026 updated by: Madona M.NOMAN, Assiut University

Effect of Magnesium Sulfate Added to Dexamethasone-Augmented Ultrasound-Guided Transversus Abdominis Plane (TAP) Block on Early Quality of Recovery and Chronic Post Operative Pain Following Open Abdominal Cancer Surgery: A Prospective Randomized Double-Blind Controlled Trial

This prospective, randomized, double-blind, controlled clinical trial is designed to evaluate whether adding magnesium sulfate to a dexamethasone-augmented, ultrasound-guided transversus abdominis plane (TAP) block improves early postoperative recovery and analgesia in adult patients undergoing open abdominal cancer surgery.

A total of 72 participants will be allocated into two groups. Both groups will receive a standard TAP block using bupivacaine and dexamethasone, while the intervention group will additionally receive magnesium sulfate.

The primary outcome of the study is the early quality of recovery assessed at 24 hours postoperatively. Secondary outcomes include postoperative pain scores, total opioid consumption, time to first rescue analgesia, the incidence of postoperative nausea and vomiting, patient satisfaction, block-related complications, intraoperative opioid requirements, hemodynamic parameters, and the incidence of chronic postoperative pain assessed through six months of follow-up.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

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

Study Contact Backup

Study Locations

  • Egypt
      • Asyut, Egypt
        • South Egypt Cancer Institute, Assiut University, Egypt
        • 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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • •Age 18-70 years.

    • ASA physical status I-III.
    • Scheduled for elective abdominal cancer surgery.
    • Able to understand the study protocol and complete the QoR-15 questionnaire. Provided written informed consent

Exclusion Criteria:

  • • Patient refusal.

    • Allergy to local anesthetics, dexamethasone, magnesium sulfate, or study medications.
    • Coagulopathy or anticoagulant therapy.
    • Local infection at the injection site.
    • Severe hepatic or renal impairment.
    • Neuromuscular disorders.
    • Chronic opioid use or chronic pain syndromes.
    • Pregnancy or lactation in females .
    • BMI >35 kg/m².
    • Cognitive impairment or inability to communicate effectively.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group D

Patients will receive bilateral ultrasound-guided TAP block using:20ml of 0.5% Bupivacaine 100mg mixed with 8mg dexamethasone (2ml) and diluted to 40ml with normal saline (18ml),20ml per side.
Drug: Bupivacaine

Patients will receive bilateral ultrasound-guided TAP block using:20ml of 0.5% Bupivacaine 100mg total volume 40ml ,20ml volume per side in both groups.

Drug: Dexamethasone

Dexamethasone 8 mg will be administered as an adjunct to TAP block in both groups
Experimental: Group DM

Patients will receive bilateral ultrasound-guided TAP block using:20ml of 0.5% Bupivacaine 100mg mixed with 8mg dexamethasone (2ml),250mg magnesium sulfate (2.5ml) and diluted to 40ml with normal saline (15.5ml),20ml per side
Drug: Bupivacaine

Patients will receive bilateral ultrasound-guided TAP block using:20ml of 0.5% Bupivacaine 100mg total volume 40ml ,20ml volume per side in both groups.

Drug: Dexamethasone

Dexamethasone 8 mg will be administered as an adjunct to TAP block in both groups

Drug: Magnesium sulfate

Magnesium sulfate 250 mg will be administered as an adjunct to TAP block in DM group only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Recovery-15 (QoR-15) score
Time Frame: 24 hours postoperatively

The Quality of Recovery-15 questionnaire will be used to assess the quality of postoperative recovery 24 hours after surgery, evaluating five dimensions: physical comfort, emotional state, psychological support, physical independence, and pain, resulting in a total score ranging from 0 to 150 (higher scores indicate better recovery).
24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Postoperative Opioid Consumption
Time Frame: During the first 24 hours postoperatively

Measuring the total morphine consumption required by the patient as rescue analgesia.
During the first 24 hours postoperatively
Time to First Request for Rescue Analgesia
Time Frame: Within the first 24 hours postoperatively

Recording the duration from the end of surgery until the patient first requests rescue analgesia (when Visual Analogue Scale (VAS)is 4 or more).
Within the first 24 hours postoperatively
Mean Arterial Pressure (MAP)
Time Frame: At baseline, after block, every 15 minutes intraoperatively, and at the end of surgery (extubation period).

Assessing Mean Arterial Pressure (MAP) values
At baseline, after block, every 15 minutes intraoperatively, and at the end of surgery (extubation period).
Chronic Postoperative Pain
Time Frame: Through 6 months postoperatively

Assessing the presence or absence of chronic postoperative pain and its intensity using the Visual Analogue Scale (VAS)ranging from 0 (no pain) to 10 (worst imaginable pain)minimum value of 0, maximum value of 10, where higher scores mean a worse outcome.
Through 6 months postoperatively
Postoperative Pain Intensity
Time Frame: At arrival to Post- Anesthesia Care Unit (PACU) (0 hour), 2, 4, 6, 12, and 24 hours postoperatively.]

Evaluating postoperative pain intensity using the Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).
At arrival to Post- Anesthesia Care Unit (PACU) (0 hour), 2, 4, 6, 12, and 24 hours postoperatively.]
Patient Satisfaction
Time Frame: At 24 hours postoperatively

Evaluating patient satisfaction with postoperative pain management using a 5-point Likert scale (ranging from very dissatisfied to very satisfied)(minimum value of 1, maximum value of 5, where higher scores mean a better outcome).
At 24 hours postoperatively
TAP Block-Related Complications and Adverse Effects
Time Frame: Intraoperatively and throughout the 24-hour postoperative period

Evaluating the overall incidence of any block-related complications or adverse events (including block failure, local anesthetic systemic toxicity, hematoma, infection, pneumothorax, nerve injury, or magnesium-related side effects), reported as the percentage of affected patients out of the total study population
Intraoperatively and throughout the 24-hour postoperative period
Intraoperative Fentanyl Requirements
Time Frame: Intraoperatively (during the surgical procedure)

Measuring the total intraoperative consumption of fentanyl.
Intraoperatively (during the surgical procedure)
Postoperative Nausea
Time Frame: During the first 24 hours postoperatively

Recording the incidence of postoperative nausea episodes
During the first 24 hours postoperatively
Postoperative Vomiting
Time Frame: During the first 24 hours postoperatively

Recording the incidence of postoperative vomiting episodes.
During the first 24 hours postoperatively
Heart rate
Time Frame: At baseline, after block, every 15 minutes intraoperatively, and at the end of surgery (extubation period)

Assessing heart rate values.
At baseline, after block, every 15 minutes intraoperatively, and at the end of surgery (extubation period)
Oxygen Saturation (SpO2)
Time Frame: At baseline, after block, every 15 minutes intraoperatively, and at the end of surgery (extubation period)

Assessing peripheral oxygen saturation levels.
At baseline, after block, every 15 minutes intraoperatively, and at the end of surgery (extubation period)

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Madona M Noman, MD, 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 (Estimated)

December 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

November 4, 2026

First Submitted That Met QC Criteria

November 4, 2026

First Posted (Actual)

November 10, 2026

Study Record Updates

Last Update Posted (Actual)

November 10, 2026

Last Update Submitted That Met QC Criteria

November 4, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SECI-IRB 18-2026-849

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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