跳至主要内容
临床试验/CTRI/2020/02/023197
CTRI/2020/02/023197已完成1 期

Comparision between plain Ropivacaine, Ropivacaine with Buprenorphine and Ropivacaine with Clonidine for intrathecal use in lower limb orthopaedic surgeries - A prospective randomized controlled clinical trial

Vasanth D1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2020年10月2日最近更新:

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
To compare duration of analgesia of Ropivacaine, Buprenorphine with ropivacaine, Clonidine with ropivacaine given intrathecally in terms of first

研究概览

简要总结

This is randomised controlled trial to compare the plain ropivacaine, Buprenorphine with ropivacaine and Clonidine with ropivacaine given intrathecally for patient undergoing lower limb orthopaedic surgeries,among 75 patients are divided in 3 groups over a period of 18 months.The primary objective is to compare the duration of analgesia between 3 groups.The secondary objectives are onset of sensory blockade, haemodynamic changes during intra operative period and quality of analgesia post operatively.

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

入选标准

  • Patients undergoing elective upper limb surgeries American Society of Anaesthesiologist I or II.

排除标准

  • Patient refusal.
  • Allergic to opioids/ local anaesthetics.
  • Height < 140 cm , BMI > 30 Patient with recent history of CVA.
  • Coagulation disorder.
  • Severe CVS abnormalities.
  • Poorly controlled hypertension.
  • Poorly controlled Diabetes mellitus.
  • Emergency orthopaedic surgery.

结局指标

主要结局

To compare duration of analgesia of Ropivacaine, Buprenorphine with ropivacaine, Clonidine with ropivacaine given intrathecally in terms of first

时间窗: Post operative period

rescue analgesia requirement

时间窗: Post operative period

次要结局

  • Time taken for onset of sensory and motor blockade.(Intra operative haemodynamic changes.)

研究者

发起方
Vasanth D
申办方类型
Other [self]

研究点 (1)

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