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临床试验/CTRI/2025/10/095872
CTRI/2025/10/095872尚未招募不适用

Post-operative pain relief with intra-articular Bupivacaine alone and in combination with aqueous Diclofenac or Dexmedetomidine in patients undergoing arthroscopic anterior cruciate ligament reconstruction

Maulana Azad Medical College1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2025年10月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
39
试验地点
1
主要终点
Pain assessment by visual analogue score (VAS) in post operative period.

研究概览

简要总结

Anterior Cruciate Ligament (ACL) injury is a very common problem of the knee, especially in athletes. Anterior Cruciate Ligament injury is a functionally disabling condition, also it is a common etiology of knee instability and dysfunction, and it also predisposes the knee for early onset of degenerative changes in the knee.

The aim of the treatment is to provide a stable joint which allows one to return to preinjury level of activity, improve knee-related quality of life, and avoid the late sequelae of an anterior cruciate ligament deficient knee. Anterior Cruciate Ligament reconstruction gives predictable and good results with various objective and subjective scores.

Post-operative pain is often encountered as a major obstacle delaying hospital discharge and preventing early rehabilitation. Systemic opioid and non-opioid agents have been tried previously for pain relief. It has been observed that through intraarticular injections a number of systemic adverse effects can be avoided. The most preferred local anesthetic is Bupivacaine, which has been reported to have higher success rates. Intra-articular administration of local anesthetics provides adequate but short-term analgesia. Hence, various adjuvant agents need to be added to the local anesthetics; among which opioids are the most used.

The aim of this study will be to compare the postoperative analgesic efficacy of intra-articular injection of bupivacaine alone vs when it will be combined with aqueous diclofenac or dexmedetomidine.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Double

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients of age 18 to 50 years have an anterior cruciate ligament tears who undergoing primary arthroscopic anterior cruciate ligament reconstruction.

排除标准

  • History of cardiovascular or pulmonary or hepatic or renal or neuropsychiatric or endocrine diseases or acid peptic disease or alcohol or drug addiction Chronic pain treatment or hypertension treated with alpha methyldopa or Clonidine or beta adrenergic blockers Pregnant women and nursing women Body mass index more than 35 kg per metre square Bony ACL avulsion and other ligaments or meniscus requiring surgery History of allergy to the drugs being used in the study.

结局指标

主要结局

Pain assessment by visual analogue score (VAS) in post operative period.

时间窗: Visual analogue score (VAS) at 3rd, 6th, 12th, 24th, 36th, and 48th hours post operatively.

次要结局

  • 1. Time duration since surgery to first dose of rescue analgesia.(2. Total post operative analgesia requirement in the first 48 hours.)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Manoj Kumar Meena

Maulana Azad Medical College

研究点 (1)

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