Acupuncture for Pain Relief During Perineal Repair After Childbirth

Sonderborg Hospital

Status: Completed

Conditions: Lacerations; Pain; Birth Injuries

Treatments: Drug: lidocaine 10mg/ml; Procedure: acupuncture in 6 specific points

Study type: Interventional

Funder types: Other

Identifiers

NCT00328796

11295 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 207 patients

Sex: Female

Ages: 15 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind