Trials / Completed
CompletedNCT00328796
Acupuncture for Pain Relief During Perineal Repair After Childbirth
Acupuncture or Local Anaesthetics for Pain Relief During Perineal Repair After Vaginal Delivery: A Randomised Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 207 (actual)
- Sponsor
- Sonderborg Hospital · Other Government
- Sex
- Female
- Age
- 15 Years – 50 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | acupuncture in 6 specific points | |
| DRUG | lidocaine 10mg/ml |
Timeline
- Start date
- 2006-05-01
- Primary completion
- 2007-07-01
- Completion
- 2008-02-01
- First posted
- 2006-05-22
- Last updated
- 2008-10-06
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT00328796. Inclusion in this directory is not an endorsement.