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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02905695
Other study ID # 2010/44
Secondary ID
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


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
See also
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Completed NCT02762357 - PMCF-study Using Novosyn® Quick Suture Material for Perineal Repair After Episiotomy
Completed NCT00070720 - Improving Perinatal Care in Latin America Phase 4
Completed NCT03084549 - Study of the Analgesic Effect of the Perineal Infiltration of Ropivacaine 0.75% Versus Placebo in Post-episiotomy Perineal Pain Phase 3
Not yet recruiting NCT06415877 - The Effect of the Modified Simulation Model on Self-Efficacy, Anxiety, and Academic Motivation in Episiotomy Training N/A
Recruiting NCT05345600 - MILTA vs Placebo Use Comparison for the Management of Pain Related to Perineal Scars Following Delivery N/A
Active, not recruiting NCT02615236 - Prospective Evaluation of Perineal Ultrasound in Thr Delivery Room to Improve the Diagnosis of OASIS N/A
Recruiting NCT02847936 - Efficacy of Triclosan-coated Sutures in the Episiotomy Phase 4
Withdrawn NCT02796547 - Effect of Levobupivacaine Infiltration on the Post Partum Perineal Pain in Episiotomy, in Primiparous Women After Instrumental Delivery Phase 2
Not yet recruiting NCT05905263 - The Effect of Virtual Reality Application on Student Satisfaction, Self-Confidence, and Anxiety Levels N/A
Not yet recruiting NCT03780530 - Different Techniques for Perineal Skin Closure During Mediolateral Episiotomy Repair Phase 3
Completed NCT02911779 - The Optimal Angle of Mediolateral Episiotomy at Crowning of the Head During Labor N/A
Completed NCT02608671 - Adhesive Tape in Episiotomy Repair Phase 4
Completed NCT05776849 - Flipped Classroom in Episiotomy Education N/A
Completed NCT00265421 - Study of Different Suturing Techniques for Perineal Repair After Delivery N/A
Completed NCT05486624 - The Effect of Reiki Application on Episiotomy and Perineal Pain N/A
Completed NCT00196508 - A Study Comparing Topical Skin Adhesive or Sutures for Closure Due to Episiotomy or Perineal Tears Following Childbirth Phase 3