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Auricular Acupuncture as Effective Pain Relief After Episiotomy

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ClinicalTrials.gov Identifier: NCT03534869
Recruitment Status : Completed
First Posted : May 23, 2018
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Andro Košec, MD, PhD, University Hospital "Sestre Milosrdnice"

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.


Condition or disease Intervention/treatment Phase
Acupuncture, Ear Episiotomy; Complications Pain, Labor Procedure: Ear acupuncture Drug: Analgesics Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Auricular Acupuncture as Effective Pain Relief After Episiotomy: A Prospective Interventional Randomized Parallel Single-center Study
Actual Study Start Date : November 1, 2016
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : April 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Ear Acupuncture and Oral Analgesics

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
French auriculotherapy guidelines - internal genital area, external genital area and Shen Men point.
Other Name: Ear, acupuncture

Active Comparator: Oral Analgesics Only
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
Oral ibuprofen was given as first line therapy, while oral paracetamol was given as second line therapy.
Other Name: Oral analgesics




Primary Outcome Measures :
  1. Pain relief [ Time Frame: Immediately after birth, 2 hours after birth, during the first 3 days-at rest and activity. ]
    Level of pain intensity measured by VAS - Visual Analogue Scale score ranging from 1 (smallest pain level) to 10 (highest pain level).


Secondary Outcome Measures :
  1. Oral analgesics amount [ Time Frame: First 3 postpartal days. ]
    Amount of given analgesics in miligrams per patient per day during the first 3 postpartal days.

  2. Postpartum bleeding and pain due to uterine contractions [ Time Frame: First 3 postpartal days. ]
    Subjective levels of postpartum bleeding and pain due to uterine contractions recorded.

  3. Number of analgesic repetitions during the day. [ Time Frame: First 3 postpartal days. ]
    Number of times patients required oral analgesic therapy (N).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Healthy pregnant women over 18 years of age, a minimum of 36 weeks' gestation that underwent mediolateral episiotomy during vaginal delivery.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03534869


Locations
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Croatia
University Hospital Center Sestre milosrdnice
Zagreb, Croatia, 10000
Sponsors and Collaborators
University Hospital "Sestre Milosrdnice"
Investigators
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Study Chair: Andro Košec, MD, PhD Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Center Sestre milosrdnice

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Responsible Party: Andro Košec, MD, PhD, Consultant in Otorhinolaryngology and Head and Neck Surgery, University Hospital "Sestre Milosrdnice"
ClinicalTrials.gov Identifier: NCT03534869     History of Changes
Other Study ID Numbers: 14280 / 16-4
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: All statistical data gathered from the study, no identifiable patient records.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andro Košec, MD, PhD, University Hospital "Sestre Milosrdnice":
auricular acupuncture
episiotomy
acupuncture
pain relief
analgesic therapy
Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Ibuprofen
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action