Post-partum Perineal Pain - Chirocaine®

Phase 4

Completed

Brief 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Group A	Chirocaine	Chirocaine
Group B	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Post-partum perineal pain measured by a numerical rating scale	8 hours post partum

Secondary Outcome Measures

Name	Time	Method

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