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Auricular Acupuncture as Effective Pain Relief After Episiotomy

NCT03534869 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-05-23

No results posted yet for this study

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.

Conditions

  • Acupuncture, Ear
  • Episiotomy; Complications
  • Pain, Labor

Interventions

PROCEDURE

Ear acupuncture

French auriculotherapy guidelines - internal genital area, external genital area and Shen Men point.

DRUG

Analgesics

Oral ibuprofen was given as first line therapy, while oral paracetamol was given as second line therapy.

Sponsors & Collaborators

  • University Hospital Sestre Milosrdnice

    lead OTHER

Principal Investigators

  • Andro Košec, MD, PhD · Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Center Sestre milosrdnice

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03534869 on ClinicalTrials.gov