Comparison of Intrathecal Nalbuphine Versus Intrathecal Tramadol as Adjuvants in Subarachnoid Block for Lower Limb Orthopaedic Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Duration of spinal anesthesia
研究概览
简要总结
This study compares the use of intrathecal nalbuphine versus intrathecal tramadol as adjuvant agents to local anaesthetics in subarachnoid block for lower-limb orthopaedic surgeries. The primary objective is to determine whether there is a meaningful difference between the two drugs in terms of quality and duration of intraoperative and postoperative analgesia. Secondary outcomes include onset and efficacy of sensory and motor block, time to first rescue analgesia, incidence of adverse effects, and perioperative hemodynamic stability. By evaluating these parameters, the study aims to identify which adjuvant provides superior analgesic benefits with fewer side effects in patients undergoing lower-limb orthopedic procedures.
详细描述
The effectiveness of Intrathecal Nalbuphine 1mg versus Intrathecal Tramadol 20mg as adjuvant to 0.5% hyperbaric bupivacaine in Subarachnoid block for orthopaedic surgeries of the lower limbs is studied. Primary outcomes of the study are onset of sensory block, onset of motor block, intraoperative hemodynamic stability and postoperative analgesia measured on visual analog scale. Secondary outcomes were incidence of side-effects and the need for rescue analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA Physical Status 1 and 2 Undergoing surgical correction of lower limb fracture
排除标准
- •hypersensitivity to opioids or local anesthetics patient refusal
研究组 & 干预措施
Tramadol group
Intrathecal tramadol 20mg + bupivacaine 0.5%
干预措施: Intrathecal tramadol with spinal anesthsia (Drug)
Intrathecal nalbuphine
Intrathecal nalbuphine 1 mg + bupivacaine 0.5%
干预措施: Intrathecal nalbuphine and spinal anesthesia (Drug)
结局指标
主要结局
Duration of spinal anesthesia
时间窗: up to 24 hours post operatively
Time until first rescue analgesia at VAS \<4. (Visual Analog scale measures subjective pain intensity on a continuous scale. Score 0 means no pain while 10 means most pain possible)
Duration of spinal anesthesia
时间窗: up to 24 hours post operatively
Time until first rescue analgesia at VAS \<4. (Visual Analog scale measures subjective pain intensity on a continuous scale. Score 0 means no pain while 10 means most pain possible)
次要结局
未报告次要终点
研究者
Khadija Zubair
Dr. Khadija Zubair
CMH Lahore Medical College and Institute of Dentistry