Acupuncture for Pain Relief During Perineal Repair After Childbirth

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00328796
• Other study ID #: 11295
• Status: Completed
• Phase: N/A
• First received: May 19, 2006
• Last updated: October 3, 2008
• Start date: May 2006
• Est. completion date: February 2008

Study information

• Verified date: September 2008
• Source: Sonderborg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: February 2008
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Birth Injuries
• Lacerations
• Pain

Intervention

Procedure:
• acupuncture in 6 specific points

Drug:
• lidocaine 10mg/ml

Locations

Country	Name	City	State
Denmark	Obstetric Departments in the Hospitals of Southern Denmark	Sønderborg	Region South Denmark

Sponsors (4)

Lead Sponsor	Collaborator
Sonderborg Hospital	Aase and Ejnar Danielsens Foundation, The Augustinus Foundation, Denmark., The Danish Midwifery Organization

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for additional pain relief during the perineal repair
Primary	Pain experienced during perineal repair reported 1 day after delivery
Primary	Wound healing evaluated 1 and 14 days after delivery
Secondary	Patient satisfaction with the given pain relief