Acupuncture for Pain Relief During Perineal Repair After Childbirth

Not Applicable

Completed

• Conditions: Birth Injuries; Lacerations; Pain

• Registration Number: NCT00328796
• Lead Sponsor: Sonderborg Hospital

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 Description

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.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-19
• Study First Submitted QC: 2006-05-19
• Study First Posted: 2006-05-22
• Primary Completion: 2007-07
• Study Completion: 2008-02
• Status Verified: 2008-09
• Last Update Submitted: 2008-10-03
• Last Update Posted: 2008-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 207

Inclusion Criteria

• Primipara
• Healthy mother and child
• Danish speaking
• Perineal laceration or episiotomy that can be sutured by a midwife.

Exclusion Criteria

• Large perineal lacerations
• Heavy bleeding after childbirth
• No need for pain relief

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction with the given pain relief

Trial Locations

Locations (1)

Obstetric Departments in the Hospitals of Southern Denmark; 🇩🇰 Sønderborg, Region South Denmark, Denmark