Post-partum Perineal Pain – Chirocaine®
Overview
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.
Full Title of Study: “Contribution of the Local Infiltration of Chirocaine® in the Management of the Post-partum Perineal Pain After Episiotomy or First-degree Tear”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: January 2015
Interventions
- Drug: Chirocaine
- Other: Placebo
Arms, Groups and Cohorts
- Experimental: Group A
- Chirocaine
- Placebo Comparator: Group B
- Placebo
Clinical Trial Outcome Measures
Primary Measures
- Post-partum perineal pain measured by a numerical rating scale
- Time Frame: 8 hours post partum
Participating in This Clinical Trial
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.
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 45 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Hopital Foch
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Jean-Marc Ayoubi, MD, PhD, Principal Investigator, Hopital Foch
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