Comparison of Intrathecal Hydromorphone and Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Post Operative Fentanyl PCA Consumption
研究概览
简要总结
The use of intrathecal opioids for analgesia in the setting of cesarean section has become standard obstetric anesthesia practice. Currently, two opioids are commonly used. These opioids are fentanyl and morphine (Duramorph). Intrathecal opioids are an excellent source of analgesia and act to reduce the stress response to surgery.
Currently, most obstetric anesthesiologists use intrathecal morphine for analgesia after cesarean delivery. Morphine provides excellent analgesia for cesarean section. However, use of this medication is associated with side effects such as pruritus and nausea and vomiting.
Recently, multiple obstetric anesthesia groups began to use intrathecal hydromorphone for cesarean delivery when morphine was unavailable. As groups began to use hydromorphone, retrospective data became available that demonstrated its safety and efficacy for use during cesarean section.
In order to fully elucidate the analgesic and side effect properties of hydromorphone for cesarean delivery, a prospective randomized, double blind study comparing morphine and hydromorphone is necessary. The investigators need to understand whether hydromorphone is as effective as morphine for analgesia after cesarean section, and whether it is associated with fewer or more side effects. The results of the study will allow providers to make educated decisions to better care for their patient.
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)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Elective primary cesarean section
- •Females age 18-40
排除标准
- •Emergency cesarean section
- •Anesthetic other than spinal
- •History of chronic pain or pre-op opioid use
- •Allergy to morphine or hydromorphone
研究组 & 干预措施
Intrathecal morphine
0.25mg ( 250mcg) intrathecal morphine added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections
干预措施: Intrathecal morphine (Drug)
Intrathecal hydromorphone
50mcg intrathecal hydromorphone added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections.
干预措施: Intrathecal hydromorphone (Drug)
结局指标
主要结局
Post Operative Fentanyl PCA Consumption
时间窗: at 24 hours
Total dose of fentanyl patient controlled analgesia (pca) used in 24 hours post-op.
次要结局
- Patient Satisfaction Score(at 24 hours)
- Symptom Scale for Two Specific Side Effects of Nausea and Pruritus(up to 24 hours)
- Time to Initial PCA Use(up to 24 hours)
- Pain Score(at 24 hours)
研究者
Yaakov Beilin
Professor of Anesthesiology
Icahn School of Medicine at Mount Sinai