CTRI/2025/04/085739尚未招募不适用
Nalbuphine versus Fentanyl as an Intrathecal Adjuvant to Hyperbaric Bupivacaine in Lower Limb Orthopaedic Surgeries
Veer Surendra Sai Institute of Medical Sciences and Research1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年5月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Duration of effective postoperative analgesia provided by intrathecal Nalbuphine and Fentanyl when used as adjuvants to hyperbaric Bupivacaine in patients undergoing lower limb orthopedic surgeries.
研究概览
简要总结
This trial nalbuphine versus fentanyl as an intrathecal adjuvant to hyperbaric bupivacaine in lower limb orthopaedic surgeries will be undertaken to compare the duration of anaesthesia and postoperative analgesia of both the drugs in terms of onset of sensory and motor block and duration of blocks and also compare the hemodynamic stability and incidence of adverse effects of both drugs.
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 aged between 18–60 years Belonging to ASA Physical Status I or II Of either sex Undergoing elective lower limb orthopedic surgery under spinal anesthesia.
排除标准
- •Patients who did not give informed consent Known hypersensitivity to any of the study drugs Pregnancy Coagulation disorders, spinal deformities, local infection at the puncture site, or contraindications to spinal anesthesia.
结局指标
主要结局
Duration of effective postoperative analgesia provided by intrathecal Nalbuphine and Fentanyl when used as adjuvants to hyperbaric Bupivacaine in patients undergoing lower limb orthopedic surgeries.
时间窗: 24 hours
次要结局
- 1. To compare the onset time of sensory & motor blockade between the Nalbuphine & Fentanyl groups.(2. To assess the duration of sensory & motor blockade produced by each adjuvant.)
研究者
研究点 (1)
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