MedTrace Logo

Post-partum Perineal Pain - Chirocaine®

NCT02905695 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2016-09-19

No results posted yet for this study

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.

Conditions

  • Post-partum Perineal Pain
  • Episiotomy
  • Vaginal Tear

Interventions

DRUG

Chirocaine

OTHER

Placebo

Sponsors & Collaborators

  • Hopital Foch

    lead OTHER

Principal Investigators

  • Jean-Marc Ayoubi, MD, PhD · Hopital Foch

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2015-01-31
Completion
2016-07-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02905695 on ClinicalTrials.gov