Post-partum Perineal Pain - Chirocaine®

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hopital Foch
• Treatments: Bupivacaine; Levobupivacaine

Criteria

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.