CTRI/2021/05/033578尚未招募不适用
A Randomised double blind control study of the analgesic efficacy of intrathecal nalbuphine and butorphanol as adjuvants to isobaric 0.5% Ropivacaine in lower limb orthopaedic surgeries.
Melmaruvathur Adhiparasakthi institute of Medical Sciences and Research1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年1月6日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- postoperative analgesia using VAS pain scale
研究概览
简要总结
this study ia a randomised double blinded trail comparing the effectiveness of adding butorphanol and nalbuphine to intrathecal 0.5% isobaric ropivacaine in comparison with plain isobaric 0.5% ropivacaine for lower limb orthopedic surgeries that will be conducted in Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research.Primary outcome will be postoperative analgesic effect using VAS pain Score.Secondary outcomes will be return to Bromage Score 0,hemodynamic parameters(heart rate,mean arterial pressure and oxygen saturation) and time to void.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 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
- •Age 18-60 years Both gender American Society of anaesthesiologists(ASA) physical status I and II Patients undergoing lower limb orthopaedic surgeries under subarachnoid block.
排除标准
- •Patient refusal ASA 3 and 4 Patients with local infection at the site of injection .
- •Patients with known or ascertained hypersensitivity to local anaesthetics.
- •Patient with coagulopathy, bleeding disorders and/or on treatment with anti-coagulants.
- •Spinal deformities.
- •Pregnant women and lactating women -Other contraindications for spinal anaesthesia.
结局指标
主要结局
postoperative analgesia using VAS pain scale
时间窗: postoperative period-2nd 4th 6th 8th 12th 16th 20th and 24th hours
次要结局
- Hemodynamic parameters(Heart rate,Mean arterial pressure,Oxygen saturation)(baseline,2minutes,4minutes,6minutes,8minutes,10minutes,15minutes,30minutes,45minutes)
- time to void(postoperative period upto 24hours)
- Return to bromage score zero(postoperative period upto 4hours)
研究者
研究点 (1)
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