Pain Control With Total Knee Replacement: Does Gabapentin Affect Narcotic Usage and Functional Outcome? A Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Patient Pain Scores
研究概览
简要总结
The purpose of this project is to study the effects of gabapentin on pain control in the perioperative and post-operative period of total knee arthroplasty.
详细描述
Being able to understand and better control pain in patients undergoing total knee arthroplasty will help in many different areas of medicine. Gabapentin is one pain control modality that has been used by many different orthopaedic surgeons with excellent retrospective results. Gabapentin, however, has never been studied, to the investigators knowledge, in a prospective randomized fashion in the United States for total knee arthroplasty. This study will be the first of its kind to truly compare the effects of gabapentin, a drug that has been proven safe in many other areas of medicine, with placebo for total knee arthroplasty by analyzing post-operative narcotic usage, function and sleep quality.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Age > 25 years old
- •Primary osteoarthritis of the knee
- •Must be undergoing unilateral total knee arthroplasty
- •Anesthesia assesment score I, II, or III
排除标准
- •Severe joint malalignment (defined as varus/valgus angle > 20 deg)
- •Use of gabapentin pre-operatively
- •History of chronic pain (currently under treatment)
- •History of substance abuse
- •Impaired kidney function (defined as creatinine > 1.5)
- •Epilepsy (currently on medication for treatment)
- •Known allergy to Gabapentin
- •Known history of depression or suicidal thoughts and behaviors
- •Anyone who is not a candidate for general anesthesia or any other portion of the investigator's standard of care.
研究组 & 干预措施
Gabapentin
Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
干预措施: Gabapentin (Drug)
Placebo
Placebo 600 mg po preoperatively and continued postoperatively 300 mg po q8hours X 3 days
干预措施: Gabapentin (Drug)
结局指标
主要结局
Patient Pain Scores
时间窗: 3 days
Patient's pain assessed by the Visual Analog Scale (VAS - Units on a scale) on postoperative days 0, 1 and 2. Scale range: 0-100 Higher Values = More Pain
次要结局
- Narcotics Consumption(3 days)
- Knee Range of Motion(3 days)
- Patient Restfulness(3 days)