Randomised Double-Blind Placebo Controlled clinical trial to compare the efficacy of Adductor Canal Block versus Adductor canal block plus Intra-articular catheter for pain control following Total Knee Arthroplasty
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- PAIN RELIEF AS MEASURED BY VAS SCORE
研究概览
简要总结
HYPOTHESIS : Better pain relief and Range of Motion with Adductor Canal Block + Intra-articular catheter (ACB + IAC) than Adductor Canal Block alone
AIM :
*1.*To study the effectiveness of our Multimodal Pain control regime in pain management and early rehabilitation
2.To determine which of the following method provides effective pain relief and improvement in post-operative ROM
Group A: Adductor Canal Block + Intra-articular catheter (ACB +IAC)
Group B: Adductor Canal Block (ACB)
METHODOLOGY:
Sample size – 120 patients, each group 60 patients,
Group A: Adductor canal block + Intra-articular catheter group with anaesthetic drug,
Group B: Adductor canal Block + Intra-articular Catheter group with placebo (normal saline)
Randomization will be done through random numbers generated according to software. Sealed envelope will be made. Patients will not be aware of the Group they are in.
Data analysis team will also be blinded from the study.
Data collection : VAS ( Visual Analog Score) to be collected at Post operative Day 0 and Day 1 every 8th hourly; Knee Range of motion will be collected at post operative Day 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients undergoing Unilateral Primary Total Knee Replacement at Sunshine Hospitals, Secunderabad.
排除标准
- •Revision Knee Replacements, Bilateral/Staggered Knee Replacement, Creatinine>2, Infected Cases, Gross Deformity (varus>20 degrees, Fixed Flexion Deformity>15 degrees).
结局指标
主要结局
PAIN RELIEF AS MEASURED BY VAS SCORE
时间窗: every 8th hourly following surgery for 48 hours
次要结局
- RANGE OF MOTION AS MEASURED BY GONIOMETER(24 HORS POST SURGERY)
