Post-partum Perineal Pain – Chirocaine®

Overview

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.

Full Title of Study: “Contribution of the Local Infiltration of Chirocaine® in the Management of the Post-partum Perineal Pain After Episiotomy or First-degree Tear”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 2015

Interventions

  • Drug: Chirocaine
  • Other: Placebo

Arms, Groups and Cohorts

  • Experimental: Group A
    • Chirocaine
  • Placebo Comparator: Group B
    • Placebo

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hopital Foch
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jean-Marc Ayoubi, MD, PhD, Principal Investigator, Hopital Foch

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