Post-partum Perineal Pain - Chirocaine® (EPISIO)

Hopital Foch

Status and phase: Completed; Phase 4

Conditions: Post-partum Perineal Pain; Vaginal Tear; Episiotomy

Treatments: Drug: Chirocaine; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02905695

2010/44

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups, including a placebo group

Group A

Experimental group

Description:

Chirocaine

Treatment:

Drug: Chirocaine

Group B

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo