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临床试验/CTRI/2023/06/054435
CTRI/2023/06/054435已完成4 期

Comparison of post operative analgesic efficacy of dexamethasone with dexmedetomidine as an adjuvant to ropivacaine in ultrasound guided femoral nerve block in unilateral total knee arthroplasty under spinal anaesthesia: a prospective randomized control study

fortis hospital mohali1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年6月30日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
average VAS score between the two groups within first 24 hours

研究概览

简要总结

This study is a double blind prospective randomized control trial to evaluate the analgesic efficacy of dexamethasone and dexmedetomidine, as an adjuvant to 0.375% ropivacaine in ultrasound guided femoral nerve block. This study will be done on 120 ASA I -II patients undergoing unilateral total knee arthroplasty at of Fortis hospital, Mohali. All eligible and consenting patients will be explained VAS score beforehand and given intrathecal 0.5% heavy bupivacaine (dose in range of 2.8-3.4 ml) along with femoral nerve block. Under no circumstances the dose of bupivacaine will exceed 2mg/kg body weight. Patients will be divided between two groups via computer generated randomisation. For femoral nerve block, Group A will receive 8mg dexamethasone with 30ml of 0.375% ropivacaine and group B will receive 1mcg /kg dexmedetomidine with 30ml of 0.375% ropivacaine. The investigator as well as the patient will be blinded about the drug being used. Post operative VAS score and need for rescue analgesia, will be assessed for 24 hours and compared between the two groups. Any adverse effects will also be reported. Based on existing studies using said adjuvants in femoral nerve block, both dexamethasone and dexmedetomidine have been shown to prolong the duration of block and reduce the requirement of opioids. There is a dearth of studies comparing both adjuvants in femoral nerve block, hence our study aims to fill that gap in knowledge. based on similar studies in other blocks, running hypothesis is that both adjuvants provide adequate analgesia but dexamethasone might prove to have a lower over-all VAS score and requirement for rescue analgesia.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
45.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • ASA 1 and 2 consenting to participate able to comprehend and coperate posted for unilateral total knee arthroplasty.

排除标准

  • patient refusal obese patient BMI >35 ASA 3,4 patients with history of OSA or substance abuse, or chronic opiod use.
  • allergy to local anaesthetic or any drugs used in trial contra-indication to spinal anaesthesia or posted under general anaesthesia patients with hearing or cognitive dysfunction patients on anticoagulants/ history of bleeding disorders pre-existing peripheral neuropathoies.

结局指标

主要结局

average VAS score between the two groups within first 24 hours

时间窗: 0 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 14 hours, 16 hours, 18 hours,20 hours, 24 hours

次要结局

  • time of first administration of rescue analgesic(within 24 hours)
  • compare the number of patients requiring opioid bolus in the first 24 hours in each group(within 24 hours)
  • to measure the total number of opioid boluses required over the first 24 hours post operatively(within 24 hours)
  • to compare the number of patients amongst each group who report a VAS score of more than or equal to 4 within first 24 hours post operative(0 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 14 hours, 16 hours, 18 hours,20 hours, 24 hours)

研究者

发起方
fortis hospital mohali
申办方类型
Private hospital/clinic

研究点 (1)

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