跳至主要内容
临床试验/CTRI/2019/08/020573
CTRI/2019/08/020573已完成不适用

A study comparing the analgesic efficacy of single dose of epidural morphine Vs epidural morphine with ketamine in patients undergoing lumbar laminectomy with or without discectomy - A randomized controlled clinical trial

Institutional Review Board1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年10月8日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Time Taken to Receive First Rescue Analgesia

研究概览

简要总结

post operative pain is an important factor that affects recovery after surgery , epidural administration of opioids have been proven to be effective in managing post OP pain . epidural administration of NMDA antagonist has been shown to prolong post OP analgesic and reduce opioid induced central centralization of pain , prevent opioid induced hyperalgesia and opioid tolerance . in this study we are comparing administration of epidural morphine and epidural morphine with  ketamine to know which provide better analgesia in post OP lumbar laminectomy patients - in terms of time to receive rescue analgesia , total amount of rescue analgesic received . improves NRS scale .

研究设计

研究类型
Interventional
分配方式
Stratified block randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

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

入选标准

  • ASA I AND II
  • Patients Undergoing Lumbar Laminectomy And Discectomy Surgery
  • Normal Renal Functions.

排除标准

  • ASA III OR IV
  • Impaired Renal Function
  • Intraoperative CSF Leak
  • Any Contraindications to Morphine and Ketamine.

结局指标

主要结局

Time Taken to Receive First Rescue Analgesia

时间窗: 3 Hours

次要结局

  • 1. NRS score 1-10(2. Total Amount of Rescue Analgesic Consumed: Cumulative opioid Consumption)

研究者

申办方类型
Private medical college

研究点 (1)

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