Clinical Trial: Acupuncture for Pain Relief During Perineal Repair After Childbirth

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Acupuncture or Local Anaesthetics for Pain Relief During Perineal Repair After Vaginal Delivery: A Randomised Controlled Trial

Brief Summary:

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.


Detailed Summary:

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.

Sponsor: Sonderborg Hospital

Current Primary Outcome:

  • 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


Original Primary Outcome:

  • 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.


Current Secondary Outcome: Patient satisfaction with the given pain relief

Original Secondary Outcome: Patient satisfaction with the given pain relief.

Information By: Sonderborg Hospital

Dates:
Date Received: May 19, 2006
Date Started: May 2006
Date Completion:
Last Updated: October 3, 2008
Last Verified: September 2008