Comparision of two different doses of intrathecal buprenorphine as adjuvants to levobupivacaine in arthroscopic lower limb surgeries:A randomized double-blind study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- To compare duration of analgesia- Time from intrathecal injection till administration of first rescue analgesic for 24 hours
研究概览
简要总结
This study is a randomized,double blind,parallel group,comparing two different doses of intrathecal buprenorphine as adjuvants to levobupivacaine for duration of analgesia in 96 patients admitted at AIIMS Gorakhpur for elective Arthroscopic lower limb surgeries.The primary outcome measures will be to assess duration of analgesia in patients who received two different doses of buprenorphine as adjuvants to levobupivacaine. Secondary outcomes are to compare the time taken for onset of sensory block, motor block and duration of sensory block and motor block. Safety outcome will be recording and reporting of adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor 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
- •ASA Class I/II undergoing arthroscopic lower limb surgeries under subarachnoid block.
排除标准
- •o H/o hypersensitivity reaction to local anaesthetics o Uncontrolled hypertension, diabetes mellitus and morbid obesity o Contraindication to spinal anaesthesia.
- •o History of alcohol or drug abuse and patients on Chronic opioid o Patient not giving consent o Patients undergoing emergency surgery o Pregnant and lactating females.
结局指标
主要结局
To compare duration of analgesia- Time from intrathecal injection till administration of first rescue analgesic for 24 hours
时间窗: To compare duration of analgesia- Time from intrathecal injection till administration of first rescue analgesic for 24 hours
次要结局
- 1-To compare the time taken for onset of sensory block(Time taken from the end of injection to loss of pin prick sensation at T10 dermatome)
研究者
Dr Vivek Sharma
All IndiaAll India Institute of Medical Sciences,Gorakhpur