A Comparative Evaluation Analgesic Efficacy and Side Effect Profile of 1 mg vs 2 mg Epidural Morphine for Post-Vaginal Delivery Analgesia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Requirement of rescue analgesia within 24 hours of epidural morphine administration
研究概览
简要总结
This randomized controlled trial aims to bridge this knowledge gap by evaluating whether reducing the dose from 2 mg to 1 mg maintains analgesic efficacy while diminishing the side effects profile. The findings are expected to inform future practice by guiding optimal dosing strategies and supporting the development of evidence-based postpartum analgesia protocols and potentially expanding the scope of neuraxial opioid use beyond caesarean deliveries. Ultimately this study seeks to balance effective pain relief with safety and patient satisfaction and helping refine postpartum pain management in alignment with contemporary guidelines and individualized care models.
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
- 19.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women aged 19–45 years Singleton term pregnancy (more than or equal to 37 weeks) Vaginal delivery with labour epidural analgesia Able to provide informed consent.
排除标准
- •Known allergy to morphine or opioids History of chronic pain or opioid use Severe obstetric complications (eg PPH requiring transfusion) Emergency caesarean section delivery Denied consent for postpartum epidural morphine.
结局指标
主要结局
Requirement of rescue analgesia within 24 hours of epidural morphine administration
时间窗: Requirement of rescue analgesia within 24 hours of epidural morphine administration
次要结局
- Incidence and severity of side effects(within 24 hours)
- Time to first rescue analgesia(within 24 hours)
- VAS pain scores(6 and 12 and 24 hours post epidural morphine administration)
- Patient satisfaction score (0–10 scale)(AT 24 hours)
研究者
Aditya Sapra
Dept of Anaesthesiology and Critical Care, AFMC, Pune