drugset / Trial / NCT03534869

Auricular Acupuncture as Effective Pain Relief After Episiotomy

NCT03534869

Phase 3 Completed 60 enrolled University Hospital Sestre Milosrdnice
RandomizedParallel-groupOpen-labelTreatment

Summary

Background: Episiotomy is performed in up to 30% of vaginal deliveries. Previously, pain treatment following episiotomy has relied on non-steroid anti-inflammatory drugs (NSAID) as analgesics, whose use during breastfeeding remains controversial due of their transfer to the child through lactation. The aim of the study is to determine the effect of acupuncture on postpartal perineal pain following episiotomy. Methods: The study is designed as a prospective interventional randomized parallel single-center study to evaluate the effects of auricular acupuncture on pain relief after episiotomy. The population will encompass 60 patients that have had mediolateral episiotomy performed during vaginal delivery, with 29 receiving acupuncture therapy and 31 not receiving acupuncture therapy for pain relief. NSAID analgesic therapy will be made available per request.

Timeline

Start
2016-11-01
Primary completion
2017-04-30
Completion
2017-04-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule Oral
Comparator Ibuprofen Small molecule Oral

Indications

No indication recorded.