The Effect of the Combination of Pregabalin and Dexmedetomidine on the Management of Postoperative Pain in Patients Undergoing Total Knee Arthroplasty (TKA) or Total Hip Arthroplasty (THA) Under Spinal Anesthesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Patient controlled analgesics (PCA) volume
研究概览
简要总结
Pregabalin and dexmedetomidine have been introduced to manage postoperative pain. The present study aimed to evaluate the effect of the combination of two drugs on pain relief in patients undergoing total knee or hip arthroplasty under spinal anesthesia
详细描述
One hundred and twenty-four patients undergoing total knee or hip arthroplasty under spinal anesthesia were randomly assigned to either group C (n = 31, placebo), group P (n = 33, pregabalin), group PD (n = 29, pregabalin and dexmedetomidine) or group D (n = 31, dexmedetomidine). One hour before spinal anesthesia, patients received pregabalin 150 mg or placebo orally and a bolus dose of 0.5 μg /kg IV dexmedetomidine was given over 10 min before induction of spinal anesthesia, followed by a continuous infusion of 0.5 μg/kg/hr or the same calculated volume of normal saline till completion of the surgery. Clinically relevant pain for 24 h after surgery including time to first analgesic request visual analog scale (VAS), ketorolac dose, and patient controlled analgesics (PCA) volume consumed were recorded.
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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-75 years
- •One hundred and twenty-four patients with intact cognitive function to understand this study undergoing elective total knee or hip arthroplasty under spinal anesthesia
排除标准
- •Allergic and/or contraindicated to the study drugs
- •American Society of Anesthesiologists (ASA) score III and above
- •Having drug
- •Alcohol addiction
- •Renal failure
- •Diabetes mellitus
- •currently using opioids for chronic pain and/or any of the drugs studied.
研究组 & 干预措施
Group PD
combination of pregabalin and dexmedetomidine
干预措施: Pregabalin and dexmedetomidine (Drug)
Group P
pregabalin +placebo
干预措施: Pregabalin (Drug)
Group D
placebo + dexmedetomidine
干预措施: Dexmedetomidine (Drug)
Group C
placebo + placebo
干预措施: Placebo (Other)
结局指标
主要结局
Patient controlled analgesics (PCA) volume
时间窗: For 24 hours
Patient controlled analgesics (PCA) volume consumed for 24 hours after surgery
次要结局
- time to first analgesic request(for 24 hours)
- visual analog scale (VAS)(for 24 hours)
- ketorolac dose(for 24 hours)
- adverse effects(within the first 24 hours postoperatively)
研究者
Cheol Lee
Professor,M.D.,Ph.D
Wonkwang University Hospital