Post-partum Perineal Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Post-partum Perineal Pain Episiotomy Vaginal Tear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group A

Chirocaine

Group Type EXPERIMENTAL

Chirocaine

Intervention Type DRUG

Group B

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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Chirocaine

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No