MedTrace Logo

Trial Evaluating the Analgesic Efficacy of Magnesium Sulfate as an Adjuvant to Bupivacaine in Local Wound Infiltration for Patients Undergoing Modified Radical Mastectomy (MRM) With Axillary Clearance

NCT07789600 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-08-31

No results posted yet for this study

Summary

This is a double-blind, randomized, controlled clinical trial evaluating the analgesic efficacy and safety of magnesium sulfate as an adjuvant to bupivacaine for local wound infiltration in patients undergoing modified radical mastectomy with axillary clearance. Participants will be randomized to receive either magnesium sulfate 750 mg with bupivacaine or the control intervention. Postoperative pain, analgesic requirements, and safety outcomes will be assessed during the postoperative period, including a follow-up safety assessment between Day 7 and Day 14 after surgery.

Conditions

  • Modified Radical Mastectomy

Interventions

DRUG

Magnesium Sulfate 750 mg with Bupivacaine 0.5% for Local Wound Infiltration

Magnesium sulfate 750 mg added to 0.5% bupivacaine for a single intraoperative local wound infiltration following modified radical mastectomy with axillary clearance.

DRUG

Bupivacaine 0.5% + Normal Saline

A single intraoperative local wound infiltration of 0.5% bupivacaine combined with normal saline following modified radical mastectomy with axillary clearance. The planned bupivacaine dose is 100 mg (20 mL), subject to reduction if it exceeds the participant-specific maximum allowable dose based on body weight.

Sponsors & Collaborators

  • King Hussein Cancer Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-12-01
Completion
2028-03-01

Countries

  • Jordan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07789600 on ClinicalTrials.gov