Enhanced Recovery After Cesarean Section With Low Dose Intrathecal Morphine. A Prospective Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain postoperative
研究概览
简要总结
This study is designed to see the effect of low dose intrathecal morphine on promting enhanced recovery after cesarean delivery with early ambulation and reduction of hospital stay.
详细描述
Parturients showing for elective cesarean section will be randomized into 3 groups by a computer generated randomization list. Each randomization slip will be put in a sealed envelope until patient enrollment. Patients will be divided into Group C: control group, given intrathecal bupivacaine 12.5 mg. Group M25: intrathecal bupivacaine 12.5mg + morphine 25 microgram. Group M50: intrathecal bupivacaine 12.5mg + morphine 50 microgram.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females scheduled for cesarean section
- •Age: 16-45 yrs.
- •Gestation age >38 weeks.
排除标准
- •Refusal to participate.
- •Significant cardiac, hepatic or renal dysfunction.
- •History of chronic itching problem, or hyperemesis during pregnancy
研究组 & 干预措施
Group C
given intrathecal bupivacaine 12.5 mg.
干预措施: Bupivacaine Hydrochloride (Drug)
Group M25
given intrathecal bupivacaine 12.5mg + morphine 25 microgram.
干预措施: Morphine Sulfate (Drug)
Group M25
given intrathecal bupivacaine 12.5mg + morphine 25 microgram.
干预措施: Bupivacaine Hydrochloride (Drug)
Group M50
given intrathecal bupivacaine 12.5mg + morphine 50 microgram.
干预措施: Morphine Sulfate (Drug)
Group M50
given intrathecal bupivacaine 12.5mg + morphine 50 microgram.
干预措施: Bupivacaine Hydrochloride (Drug)
结局指标
主要结局
Pain postoperative
时间窗: 24 hours postoperatively
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain
次要结局
- vomiting(24 hours postoperative)
- respiratory depression(4 hours postoperative)
- itching(24 hours postoperative)
研究者
Sohair Adeeb
Principle investigator
Minia University