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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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