Efficacy of Different Doses of Pregabalin as a Multimodal Analgesic Agent in Postoperative Pain Control After Total Knee Arthroplasty - A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Difference on 100-mm Visual analog scale (VAS) Pain Score between 75 mg of Pregabalin and 150 mg of Pregabalin groups
研究概览
简要总结
The purpose of this study is to compare the efficacy of 75 mg of Pregabalin and 150 mg of Pregabalin in postoperative pain control after TKA.
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will be chosen for eligibility for the study entry. At the day before surgery date, patients who meet the eligibility criteria will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to 75 mg of Pregabalin and 150 mg of Pregabalin groups.
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
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic primary knee osteoarthritis undergoing unilateral TKA
- •Aged between 55 and 80 years old
- •Comply with protocol
排除标准
- •Allergy to any of the medications in this protocol (Pregabalin, Morphine, Paracetamol, Celecoxib, Tramadol, Aspirin)
- •Secondary osteoarthritis of the knee including autoimmune diseases and post-traumatic
- •Previous surgery on the knee
- •Contraindicated to spinal anesthesia (SB) or Adductor canal block (ACB)
- •GFR < 30ml/min, Severe Liver Function (Child-Pugh C)
- •History of seizure or cerebrovascular diseases
研究组 & 干预措施
75 mg of Pregabalin
Participant received 1 tab of 75 mg of Pregabalin and 1 tab of placebo
干预措施: Pregabalin 75mg (Drug)
150 mg of Pregabalin
Participant received 2 tabs of 75 mg of Pregabalin
干预措施: Pregabalin 150mg (Drug)
结局指标
主要结局
Difference on 100-mm Visual analog scale (VAS) Pain Score between 75 mg of Pregabalin and 150 mg of Pregabalin groups
时间窗: 6, 12, 18, 24, 48 hours & 2, 6, 12 weeks after surgery
* The 100-mm VAS pain score is a self-reported instrument assessing pain scores. * Participants will assess the VAS pain score at rest and on-movement * VAS Pain at rest is evaluated when the participant is at rest. * VAS Pain on-movement is evaluated on active extension and flexion of the operated knee using mean scores between the two. * Possible scores range from 0 (no pain) to 100 (worst imaginable pain) * Higher scores mean a worse pain
次要结局
- Difference on side effects between 75 mg of Pregabalin and 150 mg of Pregabalin groups(6, 12, 18, 24, 48 hours & 2, 6, 12 weeks after surgery)
- Difference on Range of motion between 75 mg of Pregabalin and 150 mg of Pregabalin groups(2, 6, 12 weeks after surgery)
- Difference on time to ambulation between 75 mg of Pregabalin and 150 mg of Pregabalin groups(From postoperative period until 48 hours after surgery)
- Difference on Time up-and-go test between between 75 mg of Pregabalin and 150 mg of Pregabalin groups(2, 6, 12 weeks after surgery)
- Difference on 2-minutes walking test between 75 mg of Pregabalin and 150 mg of Pregabalin groups(2, 6, 12 weeks after surgery)
- Difference on length of stay between 75 mg of Pregabalin and 150 mg of Pregabalin groups(From postoperative period until 48 hours after surgery)
- Difference on Morphine consumption between 75 mg of Pregabalin and 150 mg of Pregabalin groups(From postoperative period until 48 hours after surgery)
- Difference on Knee Society Score between 75 mg of Pregabalin and 150 mg of Pregabalin groups(2, 6, 12 weeks after surgery)
- Difference on Knee injury and Osteoarthritis Outcome Score between 75 mg of Pregabalin and 150 mg of Pregabalin groups(2, 6, 12 weeks after surgery)
研究者
Seksan Kukreja
Principal Investigator
Thammasat University