Does Peri-Operative Gabapentin Reduce Chronic Post-Thoracotomy Pain?
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- The primary objective of this study is to determine if gabapentin can decrease or prevent chronic post-thoracotomy pain.
研究概览
简要总结
The primary objective of this study is to determine if gabapentin can decrease or prevent chronic post-thoracotomy pain.
详细描述
This study is a prospective double blind randomized controlled trial evaluating the peri-operative use of gabapentin in the prevention or modulation of post-thoracotomy hyperalgesia. Treatment will consist of a 600 mg dose of gabapentin or placebo given preoperatively the night before surgery, based on a computer generated randomized assignment. The treatment group will continue to be medicated with gabapentin 300 mg twice daily for one month following surgery. Those not included in the treatment arm of the study will continue to take a placebo for the same duration. Follow-up will consist of a postoperative visit at approximately 48 hours and a one month clinical visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Undergoing non-cardiac thoracic surgeries
- •Patients determined to have impaired decisional capacity with respect to the provision of informed consent or prisoners will not be included in the study.
排除标准
- •Current gabapentin use or current treatment for neuropathic pain.
- •Pregnant or considering becoming pregnant.
研究组 & 干预措施
Gabapentin
干预措施: Gabapentin (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The primary objective of this study is to determine if gabapentin can decrease or prevent chronic post-thoracotomy pain.
时间窗: 6 Months
次要结局
未报告次要终点