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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Overall Postoperative Pain Burden During the First 24 Hours After Surgery
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Magnesium Sulfate + Bupivacaine
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.
干预措施: Magnesium Sulfate 750 mg with Bupivacaine 0.5% for Local Wound Infiltration (Drug)
Bupivacaine + 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.
干预措施: Bupivacaine 0.5% + Normal Saline (Drug)
结局指标
主要结局
Overall Postoperative Pain Burden During the First 24 Hours After Surgery
时间窗: 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.
次要结局
未报告次要终点