Effects of Pregabalin on Pain After Total Knee Arthroplasty: A Randomized, Controlled, Double-Blind Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Postoperative Pain
研究概览
简要总结
Total knee arthroplasty can cause severe postoperative pain, and patients typically receive oral opioid analgesics for over 2 weeks. Side effects of pain management may impair participation in physical therapy and diminish patient satisfaction. Anecdotally, it seems that pregabalin is very helpful to patients after total knee arthroplasty. However, pregabalin can have side effects. It is not clear how much pregabalin to prescribe. Low doses may not be effective, but use of high doses may increase the incidence and severity of side effects.The purpose of this study is to determine which dosage of pregabalin is the most effective at reducing pain after knee surgery.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with osteoarthritis scheduled for primary tricompartmental total knee arthroplasty with a participating surgeon
- •Age 18 to 80 years old
- •Planned use of regional anesthesia
- •Ability to follow study protocol
- •English speaking (primary outcome obtained via telephone call and secondary outcomes include questionnaires validated in English only)
- •Patients planning on being discharged home or to a rehabilitation center that has agreed to participate
排除标准
- •Patients younger than 18 years old and older than 80
- •Patients intending to receive general anesthesia
- •Allergy or intolerance to one of the study medications
- •Patients with an ASA of IV
- •Patients with hepatic (liver) failure
- •Patients with chronic renal (kidney) failure (Defined as estimated creatinine clearance < 30 mL/min, based on recommendation that total daily pregabalin dose be reduced to 150 mg with Clcr < 30 mL/min, CLcr=[(140-age (years)] x weight (kg)x0.85 (for female patients)/[72xserum creatinine (mg/dL)])
- •Patients with difficult to manage diabetes mellitus, including insulin-dependence
- •Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
- •Chronic opioid use (taking opioids for longer than 3 months)
- •Patients with major prior ipsilateral open knee surgery.
- •Chronic neurontin/lyrica use
研究组 & 干预措施
Control
Patients will receive 0mg of pregabalin
干预措施: Placebo (Drug)
50mg Arm
Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of post-operative day (POD)14 and one capsule at bedtime POD15, POD16.
干预措施: Pregabalin 50mg (Drug)
100mg Arm
Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
干预措施: Pregabalin 100mg (Drug)
150mg Arm
Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
干预措施: Pregabalin 150mg (Drug)
结局指标
主要结局
Postoperative Pain
时间窗: 2 weeks postoperatively
Pain assessment scale (Numeric Rating Scale) (0=no pain; 10=worst pain imaginable).
次要结局
- Opioid-Related Symptom Distress Score(2 weeks postoperatively)
- Self-assessed Sedation and Confusion(1 day postoperatively)
- Numeric Rating Scale (NRS)(3 months)
- Neuropathic Pain(3 months)
- Opioid Usage(3 months)
- Satisfaction(2 weeks)