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临床试验/CTRI/2025/11/097771
CTRI/2025/11/097771尚未招募不适用

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

Command Hospital Airforce Bangalore1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年12月1日最近更新:

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

发起方
Command Hospital Airforce Bangalore
申办方类型
Other [Command Hospital Airforce Bangalore ]
责任方
Principal Investigator
主要研究者

Dr Anuchuri Anupama Sudheera

COMMAND HOSPITAL AIRFORCE BANGALORE

研究点 (1)

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