Comparision of 0.25% Bupivacaine Vs 0.25% Bupivacaine and 0.5mcg/kg Dexmedetomidine in USG-guided Adductor Canal Block for Post-operative Pain Relief after Knee Replacement Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To compare postoperative pain relief using VAS scores at 2, 6, 12, and 24
研究概览
简要总结
This prospective, randomized clinical study will compare the efficacy of 0.25% Bupivacaine alone versus 0.25% Bupivacaine with 0.5 mcg/kg Dexmedetomidine in ultrasound-guided adductor canal block (ACB) for postoperative analgesia in unilateral total knee replacement (TKR) surgery. A total of 120 patients (ASA I–III, aged 40–85 years) undergoing elective unilateral TKR under spinal anaesthesia will be recruited and randomized into two groups (n=60 each).
Group B will receive 20 ml of 0.25% Bupivacaine, while Group D will receive 20 ml of 0.25% Bupivacaine with 0.5 mcg/kg Dexmedetomidine for ACB. Postoperative pain will be assessed using the Visual Analogue Scale (VAS) at 4, 8, 12, and 24 hours. Outcomes measured include:
- Duration of analgesia (time to first rescue analgesic)
- Total opioid (Tramadol) consumption in 24 hours
- Incidence of adverse effects (bradycardia, hypotension, sedation, nausea, vomiting, motor blockade, urinary retention)
- Patient satisfaction scores
Statistical analysis will involve t-test, Mann–Whitney U, repeated measures ANOVA, and Chi-square/Fisher’s exact test as appropriate, with p < 0.05 considered significant.
The study aims to determine whether the addition of Dexmedetomidine prolongs analgesia, reduces opioid requirement, and improves patient satisfaction without significant adverse effects, thereby contributing to enhanced recovery protocols after TKR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 85.00 Year(s)(—)
- 性别
- All
入选标准
- •ASA Physical Status I-III Scheduled for Unilateral elective total knee replacement.
排除标准
- •Allergy to Bupivacaine or Dexmedetomidine Pre-existing neurological/neuromuscular disorders Coagulopathy or on anticoagulants Severe cardiovascular disease Bilateral total knee replacement Unicondylar knee replacement.
结局指标
主要结局
To compare postoperative pain relief using VAS scores at 2, 6, 12, and 24
时间窗: To compare postoperative pain relief using VAS scores at 2, 6, 12, and 24 | hours.
hours.
时间窗: To compare postoperative pain relief using VAS scores at 2, 6, 12, and 24 | hours.
次要结局
- Duration of analgesia (from block to first rescue analgesia)(Patient satisfaction score. Hemodynamic parameters)
- Time to first rescue analgesia(Total opioid consumption in 24 hours)
研究者
Dr Anuchuri Anupama Sudheera
COMMAND HOSPITAL AIRFORCE BANGALORE
