Effect of Topical Lidocaine-prilocaine Cream Versus Rectal Meloxicam Suppository on Relief of Post-episiotomy Pain: A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- The mean difference of visual analog scale after delivery
研究概览
简要总结
Postpartum perineal pain is a very common complaint. It can have negative consequences for mother and child including disability in daily functioning for the mother; for example, it can interfere in taking care of her infant and in breastfeeding. Early pain management is thus relevant to provide relief and prevent chronicity.
Perineal pain is particularly common following childbirth. Macarthur 2004, in a prospective cohort study involving 447 women in Canada, reported an incidence of perineal pain, in the first day after birth, of 75% in women with an intact perineum
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Normal vaginal delivery
- •Mediolateral episiotomy
- •Ability to understand and the willingness to sign a written informed consent
排除标准
- •Patients who had postpartum hemorrhage
- •Patients who had manual removal of the placenta
- •Patients with contraindications to non steroidal drugs
- •Patients with a multiple perineal lacerations
研究组 & 干预措施
lidocaine-prilocaine
women will receive 5 mg lidocaine-prilocaine cream topically on the episiotomy line
干预措施: lidocaine-prilocaine cream (Drug)
meloxicam
women will receive one 15 mg meloxicam rectal suppository
干预措施: meloxicam rectal suppository (Drug)
结局指标
主要结局
The mean difference of visual analog scale after delivery
时间窗: immediately
the scale is graded from 0 to 10
次要结局
未报告次要终点
研究者
Ahmed Mohamed Abbas
Principal investigator
Assiut University