Post-partum Perineal Pain - Chirocaine®

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02905695

Acronym

EPISIO

Enrollment

110

Registered

2016-09-19

Start date

2011-01-31

Completion date

2016-07-31

Last updated

2016-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Episiotomy, Post-partum Perineal Pain, Vaginal Tear

Keywords

Post-partum Perineal pain, Episiotomy, First-degree tear

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.

Interventions

DRUGChirocaine

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Post-partum perineal pain measured by a numerical rating scale	8 hours post partum

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026