A Comparison Between Lidocaine-Prilocaine Cream (EMLA) Application And Wound Infiltration With Lidocaine For Post Caesarean Section Pain Relief : A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- TIME TO THE FIRST DOSE OF RESCUE ANALGESIC IN THE FIRST 6 HOURS
研究概览
简要总结
A Comparison Between Lidocaine-Prilocaine Cream (EMLA) Application And wound Infiltration with Lidocaine For Post Caesarean Section Pain Relief : A Randomized Controlled Trial.
详细描述
The purpose of this study is to compare the effectiveness of topically applied lidocaine-prilocaine (EMLA) cream with local anesthetic (lidocaine) infiltration on post-cesarean section pain.
Research Question:
Is lidocaine-prilocaine (EMLA) cream application effective as compared to local anesthetic (lidocaine) infiltration on post-caesarean section pain?
Research Hypothesis:
Lidocaine-prilocaine (EMLA) cream application is effective in post_caesarean section pain as compared to local anesthetic (lidocaine) infiltration.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 40 years.
- •Patient American Society of Anesthesiologists physical status І or П.
- •Gestational age of pregnancy of 37w or more.
- •Patient have no previous section or have 1or 2 previous sections.
- •Patient having no medical disorders.
- •Patient with no obstetrical complications.
排除标准
- •age below18 or above
- •Women American Society of Anesthesiologists physical status ш or more.
- •Women having more than 2 previous cesarean section.
- •Women receive cardio vascular drugs or having history of cardio vascular disease.
- •Women with Medical disorders with pregnancy as diabetes milletus.
- •Women having obstetrical complications as antepartum hemorrhage, pre-eclampsia or eclampsia.
- •Women having metabolic, hormonal, respiratory, renal and hepatic disease.
- •Women with any severe allergic condition or severe asthma.
- •Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.
研究组 & 干预措施
EMLA CREAM
EMLA CREAM 5 mg TOPICAL APPLICATION FOR CS WOUND AND ASSESSMENT FOR POST OPERATIVE PAIN IN FIRST 6 HOURS
干预措施: EMLA CREAM 5 mg (Drug)
LIDOCAINE INFILTERATION
LIDOCAINE 1 % 20 ml INFILTERATION FOR WOUND AND ASSESSMENT OF POST OPERATIVE PAIN IN FIRST 6 HOURS
干预措施: LIDOCAINE 1 % (Drug)
结局指标
主要结局
TIME TO THE FIRST DOSE OF RESCUE ANALGESIC IN THE FIRST 6 HOURS
时间窗: 6 H
次要结局
- POSTOPERATIVE PAIN ACCORDING TO VAS(24 H)
研究者
HANY AYAD IBRAHIM
RESIDENT DOCTOR
Ain Shams Maternity Hospital