Post-partum Perineal Pain - Chirocaine®

Hopital Foch110 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

110

Conditions

Post-partum Perineal Pain Episiotomy Vaginal Tear

Interventions

ChirocaineDRUG

PlaceboOTHER

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hopital Foch

Suresnes, France

Outcomes

Primary Outcomes

Post-partum perineal pain measured by a numerical rating scale

Time frame: 8 hours post partum

Data from ClinicalTrials.gov

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