Auricular Acupuncture as Effective Pain Relief After Episiotomy

NCT03534869 | Completed Phase 3

• 1 other identifier: 14280 / 16-4
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

auricular acupuncture; episiotomy; acupuncture; pain relief; analgesic therapy

Outcome Measures

Primary Outcomes (1)

• Pain relief

  Level of pain intensity measured by VAS - Visual Analogue Scale score ranging from 1 (smallest pain level) to 10 (highest pain level).

  Immediately after birth, 2 hours after birth, during the first 3 days-at rest and activity.

Secondary Outcomes (3)

• Oral analgesics amount

  First 3 postpartal days.

• Postpartum bleeding and pain due to uterine contractions

  First 3 postpartal days.

• Number of analgesic repetitions during the day.

  First 3 postpartal days.

Study Arms (2)

Ear Acupuncture and Oral Analgesics

EXPERIMENTAL

The acupuncture treatment consisted of three acupuncture needles on the dominant ear according to French auriculotherapy guidelines - internal genital area, external genital area and Shen Men point that is used to increase the anaesthetic effect according to both French and Chinese traditions. Additional oral analgesics (NSAID) could be supplied at any time upon patients request during hospitalization. Oral ibuprofen was given as first line therapy, while oral paracetamol was given as second line therapy.

Procedure: Ear acupuncture

Oral Analgesics Only

ACTIVE COMPARATOR

Postoperative standard oral analgesic therapy (NSAID) supplied at any time upon patients request during hospitalization. Oral ibuprofen would be given as first line therapy, while oral paracetamol would be given as second line therapy.

Drug: Analgesics

Interventions

Ear acupuncture PROCEDURE

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

Also known as: Ear, acupuncture

Ear Acupuncture and Oral Analgesics

Analgesics DRUG

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

Also known as: Oral analgesics

Oral Analgesics Only

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Healthy pregnant women over 18 years of age, a minimum of 36 weeks' gestation that underwent mediolateral episiotomy during vaginal delivery.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy pregnant women over 18 years of age
• a minimum of 36 weeks' gestation
• patients that underwent mediolateral episiotomy during vaginal delivery

You may not qualify if:

• any illness diagnosed during pregnancy
• unwillingness to submit to acupuncture therapy

Sponsors & Collaborators

• University Hospital Sestre Milosrdnice: lead

Study Sites (1)

University Hospital Center Sestre milosrdnice

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Acupuncture, Ear; Analgesics

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Andro Košec, MD, PhD

  Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Center Sestre milosrdnice

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Otorhinolaryngology and Head and Neck Surgery

Model Details: The study was designed as a prospective interventional randomized parallel longitudinal single-center study to evaluate the effects of auricular acupuncture on pain relief after episiotomy conducted in the Department of Gynecology and Obstetrics, University Hospital Center Sestre milosrdnice, Zagreb, Croatia. Prospective data were collected from November 2016 to April 2017. The study included healthy pregnant women over 18 years of age, a minimum of 36 weeks gestation that underwent mediolateral episiotomy during vaginal delivery. Sixty patients were included in the study. The patients were allocated either of the groups by using a heads-tails binary result coin toss method. Twenty-nine patients were treated with auricular acupuncture for episiotomy pain relief combined with oral analgesic therapy per request, while 31 patients were treated with oral analgesics per request only. In both groups, administration of oral analgesics was recorded.

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: May 23, 2018
• Study Start: November 1, 2016
• Primary Completion: April 30, 2017
• Study Completion: April 30, 2017
• Last Updated: May 23, 2018

Record last verified: 2018-05

Locations

CR (1)