Acupuncture for Pain Relief During Perineal Repair After Childbirth

Study Overview
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Brief Summary
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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
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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: 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. Patient satisfaction with the given pain relief.

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

Conditions
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Birth Injuries, Lacerations, Pain

Intervention / Treatment
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* Procedure: acupuncture in 6 specific points
* Drug: lidocaine 10mg/ml


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: acupuncture in 6 specific points|nan|
|Drug: lidocaine 10mg/ml|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with the given pain relief |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perineal, repair, episiotomies, midwives, pain relief, Episiotomy