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

A Double-Blind, Randomized Controlled 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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07789600

Enrollment

Registered

2026-08-27

Start date

2026-09-01

Completion date

2028-03-01

Last updated

2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Modified Radical Mastectomy

Brief 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.

Interventions

DRUGMagnesium 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.

DRUGBupivacaine 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult female patients (age ≥18 years) undergoing elective modified radical mastectomy (MRM) with axillary clearance. * ASA physical status I-III. * Willingness to participate and provide informed consent.

Exclusion criteria

* Allergy to bupivacaine or magnesium. * Chronic opioid use or pre-existing chronic pain conditions. * Significant renal or hepatic impairment. * Pregnancy or lactation. * Neuromuscular disorders. * Abnormal baseline serum magnesium levels (e.g., hypermagnesemia).

Design outcomes

Primary

Measure	Time frame	Description
Overall Postoperative Pain Burden During the First 24 Hours After Surgery	From the end of surgery through 24 hours postoperatively.	Area under the curve (AUC) of Visual Analogue Scale (VAS) pain scores at rest during the first 24 hours after surgery. The Visual Analogue Scale (VAS) ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate worse pain.

Countries

Jordan

Contacts

CONTACTSupervisor, Clinical Trials Unit

FZahran@KHCC.JO+962 6 5300460

CONTACTClinical Research Coordinator

aa.18586@KHCC.JO+962 788390734

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026