Post-partum Perineal Pain - Chirocaine®

Episiotomy Clinical Trial

— EPISIO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02905695
• Other study ID #: 2010/44
• Status: Completed
• Phase: Phase 4
• First received: September 11, 2016
• Last updated: September 14, 2016
• Start date: January 2011
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Episiotomy
• Post-partum Perineal Pain
• Vaginal Tear

Intervention

Drug:
• Chirocaine

Other:
• Placebo

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-partum perineal pain measured by a numerical rating scale		8 hours post partum	Yes