Acupuncture or Local Anaesthetics for Pain Relief During Perineal Repair After Vaginal Delivery: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Need for additional pain relief during the perineal repair
研究概览
简要总结
Midwives and obstetricians are currently using acupuncture for several health problems during pregnancy and childbirth. The investigators wish to determine whether acupuncture can be used as pain relief during the repair of lacerations in the female pelvic floor following childbirth.
Three acupuncture points in the ear have been reported highly effective for perineal pain relief. A scientific trial will compare acupuncture with traditional local anaesthetics when midwives conduct perineal repair just after delivery in the hospitals of Southern Denmark.
详细描述
A randomised trial has been initiated. 226 healthy primipara are invited to participate if they deliver a child after gestation week 36 and sustain a perineal laceration or an episiotomy during childbirth.
The randomisation is done using a computer-controlled voice response system and the compared treatments are:
A: Acupuncture in Shen Men, GV20, BL36 and 2 needles in the upper ear.
B: Local anaesthetics (lidocaine 10 ml/mg) directly in the wound area.
Primary outcomes are:
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primipara
- •Healthy mother and child
- •Danish speaking
- •Perineal laceration or episiotomy that can be sutured by a midwife.
排除标准
- •Large perineal lacerations
- •Heavy bleeding after childbirth
- •No need for pain relief
结局指标
主要结局
Need for additional pain relief during the perineal repair
Pain experienced during perineal repair reported 1 day after delivery
Wound healing evaluated 1 and 14 days after delivery
次要结局
- Patient satisfaction with the given pain relief