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.
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.
Allergy to bupivacaine or magnesium.
Chronic opioid use or pre-existing chronic pain conditions.
Significant renal or hepatic impairment.
Pregnancy or lactation.
Parallel
Magnesium Sulfate 750 mg with Bupivacaine 0.5% for Local Wound Infiltration
DrugMagnesium sulfate 750 mg added to 0.5% bupivacaine for a single intraoperative local wound infiltration following modified radical mastectomy with axillary clearance.
Bupivacaine 0.5% + Normal Saline
DrugA 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.
Overall Postoperative Pain Burden During the First 24 Hours After Surgery
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.
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