CTRI/2025/10/096062尚未招募2/3 期
"A comparative study of intrathecal Nalbuphine and Buprenorphine as an adjuvant to 0.5% hyperbaric Bupivacaine in lower limb orthopedic surgeries"
Dr Sanjana M B1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年10月28日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To assess the duration of analgesia
研究概览
简要总结
This study is a randomized double blind parallel group trial comparing the duration of analgesia between intrathecal Nalbuphine and Buprenorphine as an adjuvant to 0.5% hyperbaric Bupivacaine in lower limb orthopedic surgeries in 120 patients for 18 months. The primary outcome will be to compare the duration of analgesia. The secondary outcomes will be to assess onset of sensory and motor blockade, to assess duration of motor blockade, to compare hemodynamics and to assess the side effects if any.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 willing to give informed written consent
- •American Society of Anaesthesiologists physical status grade I –II aged between 18- 60 years
- •Patients weighing 50-80kgs, Patients of height 150-170cms with BMI of 22.2 to 27.7
- •Scheduled to undergo lower limb orthopaedic surgeries.
排除标准
- •Allergy to local anaesthetics
- •Infection at the site of injection
- •Coagulopathy
- •Chronic pain syndromes
- •Prolonged opioid medication
- •Chronic liver disease, chronic renal disease, and cognitive impairment
- •Combined spinal epidural anaesthesia
- •Surgeries exceeding 6 hours
- •Surgeries that are converted to general anesthesia
- •Morbid obesity (BMI more than 40)
- •Pregnancy, parturients and nursing mothers.
结局指标
主要结局
To assess the duration of analgesia
时间窗: Post operative pain will be assessed every 60 mins for 4 hours from onset of analgesia
次要结局
- 1.To assess the onset of sensory & motor blockade(2.To assess the duration of motor blockade)
研究者
Dr Sanjana M B
Bangalore Medical College and Research Institute
研究点 (1)
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