The BUMP Trial: Intrathecal Buprenorphine Versus Morphine for Postcesarean Analgesia-A Randomized Noninferiority Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Morphine equivalents administered within 24 hours after spinal administration
研究概览
简要总结
In this study the researchers are randomizing pregnant patients coming for elective cesarean delivery to receive either intrathecal buprenorphine or morphine for their analgesia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Assignments done via opaque envelopes. Separate team will break envelopes and draw up study medication.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Presenting for singleton elective cesarean delivery at term gestation.
排除标准
- •allergy to buprenorphine or morphine
- •will not have neuraxial anesthesia
- •chronic pain conditions
- •opiate based medications
研究组 & 干预措施
Buprenorphine
Patients receive 60 mcg buprenorphine as a part of their spinal medications.
干预措施: buprenorphine (Drug)
Morphine
Patients receive 125 mcg morphine as a part of their spinal medications
干预措施: morphine (Drug)
结局指标
主要结局
Morphine equivalents administered within 24 hours after spinal administration
时间窗: 24 hours
The total sum of opiates will be converted into morphine equivalents and compared between the groups for the first 24 hours after the spinal is administered.
次要结局
- Morphine Equivalents at 48 Hours(48 hours)
- Morphine Equivalents at 72 Hours(72 hours)
- Obstetric Quality of Recovery-10 (ObsQoR-10) Score(24 hours, 48 hours, and 72 hours post spinal administration)
- Pruritus Scores PACU(during PACU stay, about 6 hours)
- Pruritus Scores POD1-3(at 24 hours intervals for 72 hours)
- Floor Pain Scores over 24 hours(through 24 hours)
研究者
Daniel Katz
Professor
Icahn School of Medicine at Mount Sinai