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OpenTrials
Completed

NCT Number: NCT02905695

Post-partum Perineal Pain - Chirocaine®

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.

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Key information

Conditions

Post-partum Perineal Pain Episiotomy Vaginal Tear

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hopital Foch

Suresnes, 92150, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chirocaine

Drug

Placebo

Other

Primary outcomes

  1. Post-partum perineal pain measured by a numerical rating scale

    Time frame: 8 hours post partum

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

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

Acronym: EPISIO

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Sep 19, 2016
Registry last updated
Sep 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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