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
| Registry | NCT07789600 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: triple, supportive care |
| Enrollment | 70 (Estimated) |
| Sponsor | King Hussein Cancer Center (Other) |
| Conditions | Modified Radical Mastectomy |
| Interventions | Magnesium Sulfate 750 mg with Bupivacaine 0.5% for Local Wound Infiltration, Bupivacaine 0.5% + Normal Saline (Drug) |
| Dates | start 2026-09-01 (estimated), primary completion 2027-12-01 (estimated), completion 2028-03-01 (estimated), first posted 2026-08-27, last updated 2026-08-31 |
| Locations | 1 site in Jordan |
Related Papers Related Patents Related Grants Related Experts
All trials for Modified Radical Mastectomy All trials of Magnesium Sulfate 750 mg with Bupivacaine 0.5% for Local Wound Infiltration All trials of Bupivacaine 0.5% + Normal Saline
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Magnesium Sulfate + Bupivacaine | Experimental | Drug: Magnesium Sulfate 750 mg with Bupivacaine 0.5% for Local Wound Infiltration | Participants will receive a single intraoperative local wound infiltration following modified radical mastectomy with axillary clearance, consisting of 750 mg magnesium sulfate combined with 0.5% bupivacaine. 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. |
| Bupivacaine + Normal Saline | Active comparator | Drug: Bupivacaine 0.5% + Normal Saline | Participants will receive a single intraoperative local wound infiltration following modified radical mastectomy with axillary clearance, consisting of 0.5% bupivacaine combined with normal saline. 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. |
Sex: All, ages: 18 Years to any
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).
| Facility | City | Country | Status |
|---|---|---|---|
| King Hussien Cancer Centre | Amman | Jordan |