Pain Clinical Trial
Official title:
Acupuncture or Local Anaesthetics for Pain Relief During Perineal Repair After Vaginal Delivery: A Randomised Controlled Trial
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.
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:
1. Need for additional pain relief during the perineal repair.
2. Pain experienced during perineal repair reported 1 day after delivery.
3. Wound healing evaluated 1 and 14 days after delivery.
4. Patient satisfaction with the given pain relief.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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