Beneficial Side Effects of Topiramate in Obese Patients Undergoing Total Joint Arthroplasty, a Study of Opiate Consumption and Weight Reduction
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Determine the reduction in Opioid Consumption
研究概览
简要总结
The purpose of this study is to evaluate the effects of topiramate (TPM) in obese patients with respect to weight loss and pain after total joint replacement surgery
详细描述
Investigator hypothesize that low dose peri-operative topiramate is superior to gabapentin in reducing postoperative pain and opioid consumption after primary TJA with a more favorable side effect profile that will facilitate patient optimization via pre- and postoperative weight loss.
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
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Experiment
Topamax randomized group
干预措施: Topamax (Drug)
Control
Gabapentin randomized group
干预措施: Gabapentin (Drug)
结局指标
主要结局
Determine the reduction in Opioid Consumption
时间窗: 3 months
Postoperative morphine equivalent opiate use and opiate refill requests after discharge will be compared post randomization to receive one of the two medications for multimodal pain control.
Evaluate the Side Effect Profiles of Topiramate
时间窗: 3 months
Perioperative weight change experienced by patients will be compared after randomization to receive one of the two medications. Weight change is measured in lbs
Evaluate the Side Effect Profiles of gabapentin
时间窗: 3 months
Perioperative weight change experienced by patients will be compared after randomization to receive one of the two medications. Weight change is measured in lbs
次要结局
- Harris hip score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin(1 week)
- Harris hip score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 6 weeks(6week)
- SF12 Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 2weeks(2 week)
- WOMAC score Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 6 weeks(6 week)
- WOMAC score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 2 weeks(2 week)
- Harris hip score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 2 weeks(2 week)
- SF12- Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 6 weeks(6 week)
- SF12- Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 1 week(1 week)
- Harris hip score -Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months(3 months)
- SF12- Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months(3 months)
- WOMAC score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months(1 week)
研究者
Derek Amanatullah
Assistnat professor
Stanford University