Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia: A Randomized, Double-blinded, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Average Pain Score at Rest
研究概览
简要总结
One dose of either gabapentin or placebo will be given to patients prior to thoracotomy. Patients will also receive an epidural infusion, intravenous patient-controlled analgesia with fentanyl, oral acetaminophen and intravenous ketorolac as needed to achieve optimal analgesia. Pain ratings and supplemental medication use will be recorded for 48 hours and will also be assessed at 3 months postoperatively to determine whether the patients who received gabapentin had improved analgesia and/or required less supplemental medication than the placebo group.
详细描述
The gabapentin dose utilized is 600 mg. The epidural infusion utilizes bupivacaine 0.075% with hydromorphone 10 mcg/cc infusing at 6 cc/hour. The settings for the fentanyl patient-controlled analgesia device start at 10 mcg every 10 minutes with a 200 mcg 4 hour maximum.
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Gabapentin preoperatively
Preoperative gabapentin 600 mg orally within 2 hours prior to surgery.
干预措施: Gabapentin (Drug)
Active placebo
Diphenhydramine 12.5 mg orally 2 hours preoperatively.
干预措施: Diphenhydramine (Drug)
结局指标
主要结局
Average Pain Score at Rest
时间窗: 48 hours
Pain scores every 4 hours for 48 hours postoperatively, utilizing the numeric rating scale with 0 being no pain and 10 the most severe pain you can imagine.
Average Pain Score With Coughing the First Morning Following Surgery
时间窗: First morning following surgery
Patients were asked on the first morning following surgery how they rated their pain with coughing utilizing the Numeric Rating Scale for pain, with 0 being no pain and 10 being the worst pain imaginable. The range is 0-10.
Average Pain Score With Coughing on Second Morning After Surgery
时间窗: Second morning after surgery
Numeric rating scale pain score with coughing on second morning after surgery, range 0-10.
次要结局
- Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively(3 months postoperatively)
- Opioid Consumption in First 24 Hours Postoperatively(24 hours)
- Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) Postoperatively(48 hours postoperatively)
研究者
Michelle Kinney
Michelle A. O. Kinney, MD
Mayo Clinic