Intravenous Methadone Versus Intrathecal Morphine for Analgesia Following Cesarean Delivery: a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Total opioid consumption
研究概览
简要总结
The purpose of this study is to determine if there is a difference in opioid requirements at 0-48 hours after scheduled cesarean delivery in patients receiving 150 mcg intrathecal morphine compared to 0.2 mg/kg (maximum 20 mg) intravenous methadone.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •English-speaking
- •Age over 18 years old
- •Scheduled cesarean delivery
排除标准
- •Any contraindication to the administration of a spinal technique for anesthesia
- •History of intolerance or adverse reaction to opioid medications
- •History of chronic pain, opioid use >30 OME/day, or substance use disorder
- •History of obstructive sleep apnea, chronic obstructive pulmonary disease, or respiratory compromise (SpO2 <92% on room air, or has a pre-existing oxygen requirement)
- •History of liver or kidney failure
- •Diagnosis of pre-eclampsia with current pregnancy
- •Depression requiring more than one medication
- •Planned use of CSE technique
- •BMI >50.0 kg/m2
- •ASA status IV, V
- •No prior history of an ECG demonstrating QTc > 440ms
- •Surgical complication requiring conversion to general anesthesia
研究组 & 干预措施
Spinal Anesthesia with Intravenous Methadone
Subjects will receive spinal anesthesia (intrathecal bupivacaine with fentanyl) with intravenous methadone
干预措施: Intravenous line (IV) Methadone (Drug)
Spinal Anesthesia with Intrathecal Morphine
Subjects will receive spinal anesthesia (intrathecal bupivacaine with fentanyl) with intrathecal morphine
干预措施: Intrathecal Morphine (Drug)
结局指标
主要结局
Total opioid consumption
时间窗: 24 hours post-delivery, 48 hours post-delivery
Total opioid consumption of either intrathecal opiate or intravenous methadone at 24-48 hours after delivery.
次要结局
- Obstetric Quality of Recovery-10 (ObsQoR-10) Scoring Tool(24 hours, 48 hours, 7 days)
- Numeric Rating Scale (NRS) pain score at rest(12 hours, 24 hours, 36 hours, 48 hours, 7 days)
- Numeric Rating Scale (NRS) for movement-evoked pain(12 hours, 24 hours, 36 hours, 48 hours, 7 days)
- Numeric Rating Scale (NRS) for pain in previous 24 hours(12 hours, 24 hours, 36 hours, 48 hours, 7 days)
- Pruritus(12 hours, 24 hours, 36 hours, 48 hours)
- Richmond Agitation Sedation Scale (RASS)(12 hours, 24 hours, 36 hours, 48 hours)
研究者
Emily E. Sharpe, M.D.
Principal Investigator
Mayo Clinic