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临床试验/CTRI/2024/10/075042
CTRI/2024/10/075042尚未招募不适用

A comparative study to evaluate the post-operative analgesic effect of IPACK Block and Intrathecal Buprenorphine in patients undergoing Arthroscopic Knee Surgeries under Spinal Anaesthesia

MS Ramaiah Medical College1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2024年10月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
112
试验地点
1
主要终点
Time for the first rescue analgesia administered

研究概览

简要总结

Pain in the immediate postoperative period after knee surgeries may hinder rehabilitative programmes and cause various pathophysiological consequences. Arthroscopic knee surgery is associated with variable amount of postoperative pain, which is caused by the irritation of the free nerve endings of the synovial tissue, anterior fat pad and joint capsule during surgical excision and resection. Several analgesic strategies such as systemic drugs, central or peripheral nerve blocks and intra-articular drug administration have been used to treat post-operative pain. Peripheral nerve blocks are ideally suited for lower limb surgeries because of the peripheral location of the surgical sites and potential to block pain pathways at multiple levels.

The recent technique of ultrasound guided local anaesthetic infiltration of the interspace between popliteal artery and the capsule of the posterior knee (IPACK) has shown promising results. The technique involves a very selective block of the terminal sensory branches of the posterior aspect of the knee without involvement of motor branches of the tibial nerves and peroneal nerves leading to reduced pain without motor weakness. Hence, preserving the sensory motor function of the leg and foot. This leads to earlier ambulation, rehabilitation and recovery in various knee surgeries.

In this study we aim to evaluate the postoperative analgesic effect of IPACK block vs Intrathecal Buprenorphine in patients undergoing arthroscopic surgeries under spinal anaesthesia. We hypothesize that IPACK block with spinal anaesthesia provides longer and better analgesia in the post-operative period, compared to Buprenorphine based spinal anaesthesia.

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
25.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • All patients undergoing Arthroscopic Knee Surgeries under Spinal Anaesthesia, aged between 25 and 60 years, who fit into American Society of Anaesthesiologists (ASA I and II), with Body mass index (BMI) of less than 30 kg/m2.

排除标准

  • Allergy to local anaesthetics, Local infection in the knee joint, Contraindications to Spinal anaesthesia such as coagulopathy and tight tricuspid or mitral stenosis.

结局指标

主要结局

Time for the first rescue analgesia administered

时间窗: Time since intra-thecal injection till first rescue analgesia administered

次要结局

  • Post-operative VAS Score(VAS score at 2, 4, 6, 12 and 24 hrs postoperatively)
  • Total rescue analgesia(Total rescue analgesics administered in the first 24 hrs post-operatively)

研究者

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

Dr Subham Tripathy

MS Ramaiah Medical College

研究点 (1)

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