Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The change in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo
研究概览
简要总结
The aim of this study is to determine if the reduction in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo. We have defined clinically meaningful as a reduction by 30 Morphine equivalent doses (MED)
详细描述
Study Objectives:
The aim of this study is to determine if the reduction in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo. We have defined clinically meaningful as a reduction by 25% Morphine equivalent doses (MED) Secondary objectives are to evaluate the utility of gabapentin in reducing postoperative pain, reducing hospital length of stay, promoting faster return to baseline function (to be assessed by MDASI), preventing post thoracotomy pain syndrome (to be assessed by BPI), and reducing the rate of chronic opiate use among patients undergoing thoracic procedures.
- Primary Endpoint
The primary outcome will be the sum of the daily average morphine equivalent dose of opioids recorded from day of surgery (day 0) through 7 days after surgery, for a total of 8 days. 2. Secondary Endpoints
- Time to resuming normal activities
- Presence/absence of chronic pain at 3 and 6 months, measured by BPI
- 30, 90, 180 day opiate use (Y/N)
- MDASI on post-operative days 7, 30, 90, 180
- Basic Pain Inventory (BPI) on post-operative days 1,2, 7, 30, 90, 180
- Daily pain score during hospitalization
- Length of hospital stay
- Need for opioids at discharge
- Whether medication is stopped prior to day 25, and if so when and for what reason.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Undergoing pulmonary resection (includes metastasectomy as well as anatomic resections)
- •Must have device with email capabilities for follow up survey
排除标准
- •Requiring narcotic pain medication or Gabapentin at the time of preoperative appointment or within 30 days of surgery
- •Renal impairment requiring dialysis
- •Allergy to Gabapentin
研究组 & 干预措施
Gabapentin
used as part of a multimodal pain regimen (combination of drugs used to control pain
干预措施: Gabapentin (Drug)
Placebo
designed to be compared with a study drug to learn if the study drug has any real effect
干预措施: Placebo (Other)
结局指标
主要结局
The change in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo
时间窗: through study completion, up to 8 days
The sum of the daily average morphine equivalent dose of opioids recorded from day of surgery (day 0) through 7 days after surgery, for a total of 8 days
次要结局
未报告次要终点