Post-partum Perineal Pain - Chirocaine® (EPISIO)

September 14, 2016 updated by: Hopital Foch

Contribution of the Local Infiltration of Chirocaine® in the Management of the Post-partum Perineal Pain After Episiotomy or First-degree Tear

The aim of this placebo-controlled clinical trial is to assess the effectiveness of the local infiltration of the analgesic Chirocaïne® on perineal pain after episiotomy or first-degree tear. The pain intensity is measured in immediate postpartum period by using a numerical rating scale (NRS) at the following times: H2, H4, H8, H12, H24, H36, H48 during rest, defecation and during activities. The safety of Chirocaïne® and the patient satisfaction are also evaluated at each time.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Suresnes, France, 92150
        • Hôpital FOCH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Inclusion Criteria:
  • Patients aged 18-45 years
  • Single pregnancy.
  • Vaginal normal birth in cephalic presentation or assisted vaginal delivery by vacuum extractor.
  • Patients having a mediolateral episiotomy or a first-degree perineal tear, epidural analgesia.
  • Patients affiliated to a national insurance scheme
  • Patients who have given their written consent

Exclusion Criteria:

  • Patient not speaking, reading, writing French.
  • Multiple pregnancy.
  • Breech delivery or instrumental delivery by forceps or spatula.
  • Intact perineum.
  • No epidural analgesia.
  • Patient who represent contraindication to local anesthetics, severe arterial hypotension.
  • Previous tear requiring sutures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group B
Placebo
Other: Placebo
Experimental: Group A
Chirocaine
Drug: Chirocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Post-partum perineal pain measured by a numerical rating scale
Time Frame: 8 hours post partum
8 hours post partum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Investigators

  • Principal Investigator: Jean-Marc Ayoubi, MD, PhD, Hôpital FOCH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

September 11, 2016

First Submitted That Met QC Criteria

September 14, 2016

First Posted (Estimate)

September 19, 2016

Study Record Updates

Last Update Posted (Estimate)

September 19, 2016

Last Update Submitted That Met QC Criteria

September 14, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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