Reduction of Post-op Pain and Opioid Consumption With the Addition of Methadone in Total Hip Arthroplasty: a Double-blind Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Patient reported pain in the recovery unit after surgery
研究概览
简要总结
This randomized, double-blind controlled trial investigates whether intraoperative intravenous methadone (0.15 mg/kg based on ideal body weight) reduces acute postoperative pain and opioid consumption in patients undergoing elective total hip arthroplasty under spinal anesthesia with mepivacaine. The primary outcome is patient-reported pain on a visual analog scale (VAS) 30-60 minutes after arrival in the post-anesthesia care unit (PACU). Secondary outcomes include opioid use, pain scores over time, incidence of nausea/vomiting, and quality of recovery. A total of 162 subjects will be enrolled at MUSC surgical sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-75 years of age
- •Undergoing elective primary total hip arthroplasty with mepivacaine in the spinal anesthesia
- •Allergy to methadone or mepivacaine
- •Severe liver disease defined as Child's Pugh Class C
- •End stage renal disease requiring dialysis
- •Known diagnosis of prolonged QT syndrome
- •Currently pregnant
- •Unable to provide written, informed consent
- •Non-English speaking
排除标准
- 未提供
研究组 & 干预措施
Methadone
Patients will intraoperatively receive methadone 0.15mg/kg IV, based on ideal body weight.
干预措施: Methadone (Drug)
No Methadone
Patients will NOT receive methadone.
结局指标
主要结局
Patient reported pain in the recovery unit after surgery
时间窗: up to 24 hours after surgery ends
Patient reported hip pain on a Visual Analog Scale (VAS) from 0-100mm at approximately 30-60 minutes after arriving to the recovery unit after surgery. A lower pain score means a better outcome.
次要结局
- Opioid Consumption in the recovery unit(PACU Arrival until PACU Discharge up to 30 days)
- Time to first opioid rescue dose(up to 24 hours after surgery ends)
- Pain scores(PACU, 24 hours, 48 hours, and 72 hours post-operatively.)
- Postoperative nausea and/or vomiting(PACU through 72 hours post-operatively)
- Quality of Recovery(up to 24-hours post-operatively)
研究者
Christopher Fatora, MD
Assistant Professor-Faculty
Medical University of South Carolina