Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00328796
Status:
COMPLETED
Last Update Posted:
2008-10-06
First Post:
2006-05-19
Brief Title:
Acupuncture for Pain Relief During Perineal Repair After Childbirth
Sponsor:
Sonderborg Hospital
Organization:
Sonderborg Hospital
Study Overview
Official Title:
Acupuncture or Local Anaesthetics for Pain Relief During Perineal Repair After Vaginal Delivery A Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 mlmg 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
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 mlmg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None