ChiCTR2000028730已完成4 期
Randomized Comparison of Intrathecal Morphine Versus Standard Therapy on Post-Caesarean Delivery Quality of Recovery
Departmental funding1 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2020年2月3日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- QoR-15 Questionnaire
研究概览
简要总结
To measure the quality of recovery in parturients receiving intrathecal morphine versus standard oral therapy after elective cesarean delivery.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- None
入排标准
- 年龄范围
- 18 至 50（—）
- 性别
- Female
入选标准
- •Elective cesarean delivery under single shot spinal anesthesia;
- •Lower segment cesarean delivery with planned Pfannestiel incision;
- •ASA (American Society of Anesthesiologists) Class 1 to 2;
- •Aged >=18 years old;
- •Willing and able to give consent.
排除标准
- •Emergency cesarean delivery;
- •Indication for additional post-operative analgesics on top of usual departmental regime (e.g. classical cesarean, pre-eclampsia, post-partum hemorrhage);
- •Contraindicated to paracetamol or diclofenac (e.g. allergy, renal or liver impairment, asthma, peptic ulcer disease);
- •Allergic to morphine.
研究组 & 干预措施
Placebo group
Intrathecal saline 0.1ml
morphine group
intrathecal morphine 0.1ml
结局指标
主要结局
QoR-15 Questionnaire
时间窗: at 24 hours after surgery
次要结局
- American Pain Society Patient Outcome Questionnaire
- Incidence of clinically significant respiratory depression events
研究者
研究点 (1)
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