CTRI/2024/03/063579尚未招募2/3 期
Comparative study between intrathecal 0.5% hyperbaric levobupivacaine and 0.5% hyperbaric bupivacaine with nalbuphine as adjuvant in elective lower segment cesarean section: A randomized clinical study
Sri Guru Ram Das Institute of Medical Sciences and research1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年3月20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
- 70
- 试验地点
- 1
- 主要终点
- To evaluate the effects of bupivacaine and levobupivacaine with combination of nalbuphine in terms of onset, regression and duration of sensory and motor blockade, time to requirement of first rescue analgesia for LSCS.
研究概览
简要总结
Rationale: To compare the effectiveness of intrathecal 0.5% hyperbaric levobupivacaine and 0.5% hyperbaric bupivacaine with nalbuphine as an adjuvant in providing postoperative pain relief and patient satisfaction following elective lower segment cesarean section. The research intends to guide anesthesia choices, potentially enhancing the cesarean section recovery experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients undergoing elective LSCS.
排除标准
- •Patients with cardiovascular diseases.
- •Contraindications to regional anesthesia such as local infections/sepsis at the site of lumbar puncture, anatomical disorders of spine, shock, any bleeding disorder and patient on anticoagulants.
- •Hypersensitivity to study drugs
- •History of opioid dependence
- •Fetal distress.
结局指标
主要结局
To evaluate the effects of bupivacaine and levobupivacaine with combination of nalbuphine in terms of onset, regression and duration of sensory and motor blockade, time to requirement of first rescue analgesia for LSCS.
时间窗: till the end of surgery
次要结局
- 1. To compare the hemodyanamic effects of bupivacaine and levobupivacaine(with nalbuphine as adjuvant in elective lower segment cesarean section.)
研究者
Dr Chiteshwar Walia
Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar
研究点 (1)
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