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临床试验/CTRI/2019/08/020916
CTRI/2019/08/020916尚未招募2 期

Comparision of three different doses of nalbuphine as adjuvant to intrathecal hyperbaric bupivacaine in knee joint surgeries.

Kalinga institute of medical sciences1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年5月9日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
120
试验地点
1
主要终点
To determine the optimum dose of nalbuphine with maximum analgesic and minimal side-effects.

研究概览

简要总结

Spinal anesthesia is most commonly used technique  for lower limb surgries as it is very economical and easy to administer .However,postoperative pain control is a major concern because spinal anesthesia using only local anesthetics is associated with relatively shorter duration of action and thus early analgesic intervention is needed in postoperative period.

Various adjuvants are used to improve quality,prolong the duration of neuronal blockade and postoperative analgesia.

Nalbuphine is a  semi-synthetic opioid used as an adjuvant to sub-arachnoid blockade.

The main purpose of this study is to compare three different doses of nalbuphine and determine the optimum dose with maximum analgesic effect and mininal side-effects.

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

  • American society of anesthesiologists (ASA) Physical status I and II,patient posted for surgery of knee joint.

排除标准

  • ASA PH III and IV,Height<150cm,BMI>30,Contraindication to spinal anesthesia,H/o adverse reactions to opioids,pregnancy.

结局指标

主要结局

To determine the optimum dose of nalbuphine with maximum analgesic and minimal side-effects.

时间窗: Asessed every 15mins postoperatively till the patient receives first dose of rescue analgesia.

次要结局

  • Duration of onset and regression of snsory and motor blockade.(sennsory and motor status will be checked every 2 minutes after spinal injection for first 10 minutes,every 5 minutes for next 30 minutes,and 15mins till regression.)

研究者

申办方类型
Private medical college

研究点 (1)

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