Comparison of Intrathecal Bupivacaine With and Without Morphine for Post-operative Analgesia in Parturients Undergoing Elective Cesarean Section: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 主要终点
- NRS score
研究概览
简要总结
The goal of this clinical trial is to compare intrathecal bupivacaine with or without morphine for postoperative analgesia in patients undergoing elective cesarean section. The main questions it aims to answer are:
Is intrathecal bupivacaine with morphine superior to intrathecal bupivacaine alone for postoperative analgesia for parturients undergoing cesarean section? What is the duration of analgesia in the two groups? Researchers will compare drug intrathecal bupivacaine with morphine to a iintrathecal bupivacaine alone to see if intrathecal morphine has benefits for psotoperative analgesia .
Participants will:
Get intrathecal bupivacaine with Morphine or intrathecal bupivacaine alone during spinal anesthesia for cesarean section.
They will be followed up for NRS pain scores and side effects for 24 hours. Time to need of first rescue analgesic will be noted
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Parturients undergoing elective caesarean section under Spinal anesthesia
- •ASA PS II, III
- •> 18 years
排除标准
- •Refusal to Participate
- •Contraindications to spinal anaesthesia and adjuvants INR ≥ 1.5 Plateletes < 1,00,000/cumm Severe aortic stenosis, and/or severe mitral stenosis Infection at lumbar puncture site Known allergy to local anesthetics and opioids
- •Communication barrier
- •Height <150 cm
研究组 & 干预措施
Morphine Group
This group will receive 2.2 ml of 0.5% hyperbaric bupivacaine + 100 mcg (0.1 ml of 1 mg/ml) Morphine intrathecally during spinal anesthesia
干预措施: Intrathecal morphine with bupivacaine (Drug)
Bupivacaine Group
This group will receive 2.2 ml of 0.5% hyperbaric bupivacaine during spinal anesthesia
干预措施: Hyperbaric Bupivicaine (Drug)
结局指标
主要结局
NRS score
时间窗: 24 hours
comapre NRS score at 0,1,6,12,18,24 hours between the groups
Time to need of first rescue analgesic
时间窗: within 24 hours
time of spinal anesthesia to time of demand of first rescue analgesic
次要结局
- 24 hours analgesic consumption(24 hours)
研究者
Megha Patrabansha
Dr., Resident
Tribhuvan University Teaching Hospital, Institute Of Medicine.