NCT02905695

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
Last Updated

September 19, 2016

Status Verified

September 1, 2016

Enrollment Period

4 years

First QC Date

September 11, 2016

Last Update Submit

September 14, 2016

Conditions

Post-partum Perineal PainEpisiotomyVaginal Tear

Keywords

Post-partum Perineal painEpisiotomyFirst-degree tear

Outcome Measures

Primary Outcomes (1)

  • Post-partum perineal pain measured by a numerical rating scale

    8 hours post partum

Study Arms (2)

Group A

EXPERIMENTAL

Chirocaine

Drug: Chirocaine

Group B

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

ChirocaineDRUG
Group A
PlaceboOTHER
Group B

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

MeSH Terms

Interventions

Levobupivacaine

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Jean-Marc Ayoubi, MD, PhD

    Hopital Foch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2016

First Posted

September 19, 2016

Study Start

January 1, 2011

Primary Completion

January 1, 2015

Study Completion

July 1, 2016

Last Updated

September 19, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)