跳至主要内容
临床试验/CTRI/2023/02/049732
CTRI/2023/02/049732尚未招募不适用

comparison of dexmeditomidine as an adjunct to 0.1%ropivacaine to plain ropivacaine in adductor canal block for unilateral total knee replacement:a prospective,double blinded randomized controlled study

SIR H N RELIANCE FOUNDATION HOSPITAL AND RESEARCH CENTRE1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年2月20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
64
试验地点
1
主要终点
To investigate duration of analgesia of ACB using ropivacaine with and without dexmedetomidine after unilateral TKR in first 24 hrs ,both at rest and moving

研究概览

简要总结

The main aim of this study is to investigate the duration of analgesia of ACB using ropivacaine with and without dexmedetomidine after unilateral TKR in first 24 hrs, both at rest and moving and to record pain score and opioid consumption among 2 groups.The study population will be composed of patients of either gender,aged above 18 years and below 80 years and posted for unilateral total knee replacement under spinal anesthesia at a tertiary health care centre.Data will be collected between Jan 2023 to july 2024.Analysis of the parameters will be done after complete data collection.At any point of time,the patients  enrolled can be dropped out of the study.

Sample size is calculated as 64 in number,which will be div ided into 2 groups, control group(C) and Dexmedetomidine  group (D).Control group consisting of 0.1% Ropivacaine 20mL and Dexmedetomidine group with 0.1% Ropivacaine  + 0.5mcg/kg Demedetomoidine through adductor canal block and Pain assessment done postoperatively evry 6th hourly for 24 hours and results assessed including the Pain score, side effects of adjuvant dexmedetomidine and opiod consumption.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • ASA grade 1,2,3 scheduled for unilateral total knee replacement under spinal anesthesia BMI 20-30kg/m2.

排除标准

  • allergic to any study drugs pregnant patients patients in whom nerve block could not be performed as per methodology patients on pre operative oral opioids patients and or relatives not willing for procedure ASA grade 4 ,age <18 and >80yrs BMI >30kg/m2 patients on chronic pain medication any severe perioperative complications.

结局指标

主要结局

To investigate duration of analgesia of ACB using ropivacaine with and without dexmedetomidine after unilateral TKR in first 24 hrs ,both at rest and moving

时间窗: 6hr,12hr,18hr,24hr

次要结局

  • to evaluate opioid consumption in first 24 hours of surgery(6hr,12hr,18hr,24hr)

研究者

发起方
SIR H N RELIANCE FOUNDATION HOSPITAL AND RESEARCH CENTRE
申办方类型
Research institution and hospital

研究点 (1)

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