A Randomized, Double-blind, Placebo-controlled Trial of Gabapentin in the Post-cesarean Pain Management of Buprenorphine Patient
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Total opioid use 24 hours after cesarean delivery
研究概览
简要总结
The purpose of this study is to determine whether a perioperative course of gabapentin in parturients on buprenorphine maintenance would improve analgesia after elective cesarean delivery (CD).
详细描述
Many strategies have been suggested to improve post-CD pain management in parturients on buprenorphine. While effective pain relief can be achieved, women maintained on buprenorphine during pregnancy have been shown to require up to 50% more opioids after CD compared to women with opioid use disorder not on a maintenance regimen. The perioperative use of gabapentin has been shown to reduce pain scores and opioid consumption following a variety of surgeries, ranging from cardiac bypass to total abdominal hysterectomy. The purpose of this study is to determine whether a perioperative course of gabapentin in parturients on buprenorphine maintenance would improve analgesia after elective CD.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •singleton, term pregnancy
- •currently on buprenorphine maintenance therapy
- •scheduled for elective CD under spinal anesthesia
排除标准
- •use illicit drugs or relapse during the last trimester of pregnancy
- •positive drug screen at the time of delivery
- •allergies to any medications used in the study
- •taking prescribed gabapentin at the time of admission for CD
- •contraindications to neuraxial anesthesia or require general anesthesia for CD
- •designated ASA physical status 4 or above
研究组 & 干预措施
Gabapentin
Gabapentin 600 mg by mouth one hour prior to scheduled cesarean delivery and 400 mg by mouth every 8 hours post delivery
干预措施: Gabapentin (Drug)
Placebo
Placebo with similar appearance to gabapentin by mouth one hour prior to scheduled cesarean delivery and by mouth every 8 hours post delivery
干预措施: Placebo (Drug)
结局指标
主要结局
Total opioid use 24 hours after cesarean delivery
时间窗: 24 hours after cesarean delivery
Total opioid use tallied in morphine milligram equivalents at 24 hours after cesarean delivery
Total opioid use at time of hospital discharge after cesarean delivery
时间窗: From the end of cesarean delivery to the time of hospital discharge after cesarean delivery, approximately 4 days
Total opioid use tallied in morphine milligram equivalents from the end cesarean delivery to the time of hospital discharge after cesarean delivery
次要结局
- Pain assessment using 11-point Visual/Verbal Analog (VAS) at rest 24 hours post-partum(24 hours post-partum)
- Pain assessment using 11-point Visual/Verbal Analog (VAS) at movement 48 hours post-partum(48 hours post-partum)
- Pain assessment using 11-point Visual/Verbal Analog (VAS) at movement 30 days post-partum(30 days post-partum)
- Return to normal daily function(30 days post-partum)
- Pain assessment using 11-point Visual/Verbal Analog (VAS) at movement 4 hours post-partum(4 hours post-partum)
- Pain assessment using 11-point Visual/Verbal Analog (VAS) at rest 48 hours post-partum(48 hours post-partum)
- Pain assessment using 11-point Visual/Verbal Analog (VAS) at rest 4 hours post-partum(4 hours post-partum)
- Pain assessment using 11-point Visual/Verbal Analog (VAS) at movement 24 hours post-partum(24 hours post-partum)
- Presence of persistent pain(30 days post-partum)
- Pain assessment using 11-point Visual/Verbal Analog (VAS) at rest 30 days post-partum(30 days post-partum)
研究者
Holly Ende
Asst Professor
Vanderbilt University Medical Center