Study of the Analgesic Effect of the Perineal Infiltration of Ropivacaine 0.75% Versus Placebo in Post-episiotomy Perineal Pain

Study Overview
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Brief Summary
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Episiotomy is a common obstetric gesture (20 to 30% of deliveries by the low route). In postpartum, perineal pains associated with episiotomy are common, about 70% on D7 and persistent 13% at 5 months. Most studies of obstetrical analgesia have focussed on pain during labor or following a caesarean section. The perineal pain associated with the realization of an episiotomy has been much less studied and often undervalued. Local ropivacaine has shown its effectiveness in the reduction of postoperative pain in many indications (wall surgery, hemorrhoidectomy, infiltration of trocar scars during laparoscopy). This product has the advantage of being well tolerated, easy access and administration. Three recent studies compared the post-episiotomy analgesic efficacy of local ropivacaine versus lidocaine versus placebo and lidocaine versus no infiltration. Two of these studies showed statistically significant results. However, they focused on the results at 24 and 48 hours and did not evaluate the analgesic efficacy in the medium and long term.

Official Title
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Study of the Analgesic Effect of the Perineal Infiltration of Ropivacaine 0.75% Versus Placebo in Post-episiotomy Perineal Pain: a Randomized, Double-blind Study

Conditions
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Episiotomy

Intervention / Treatment
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* Drug: Administration of Ropivacaïne
* Drug: Administration of placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major Patient (≥ 18 years) Term ≥ 37 weeks of amenorrhea Right medio-lateral episiotomy performed for medical need Delivery of a single fetus in a cephalic presentation with or without instrumental extraction Delivery under epidural anesthesia Patient to be monitored over 6 months of study Patient in ability to understand protocol Patient having given consent and signed informed consent Patient with social coverage Exclusion Criteria: Hypersensitivity or known allergy to Ropivacaine or to other amide-linked local anesthetics or to any of the excipients General contraindication specific to local anesthesia, irrespective of the local anesthetic used Contraindication for Ropivacaine- Obstetric paracervical anesthesia Hypovolemia Weight <50 kg Contra-indication or refusal of the epidural Poor understanding of the French language Substance addiction. Chronic pain syndrome. Severe hepatic or renal impairment. Acute porphyria. Caesarean section programmed. Tear of the 3rd degree according to the associated French classification. Refusal to participate in the study Patient under tutelage, curatorship, or deprived of liberty

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaïne<br> | Drug: Administration of Ropivacaïne<br>* Administration of Ropivacaïne in the margins of the episiotomy<br>|
| Placebo Comparator: Placebo<br> | Drug: Administration of placebo<br>* Administration of placebo in the margins of the episiotomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the analgesic efficacy of ropivacaine 75 mg infusion versus placebo (physiological saline) in patients with right mid-lateral episiotomy during postpartum D7 delivery. | Digital pain scale | 7 days after episiotomy |