CompletedPhase 4

Post-partum Perineal Pain - Chirocaine®

France110 participantsStarted 2011-01

Plain-language summary

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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Post-partum perineal pain measured by a numerical rating scale

Timeframe: 8 hours post partum

Trial details

NCT IDNCT02905695

SponsorHopital Foch

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-01

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