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

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

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.

Study Overview

• Status: Completed
• Conditions: Episiotomy
• Intervention / Treatment: Drug: Administration of Ropivacaïne; Drug: Administration of placebo

• Study Type: Interventional
• Enrollment (Actual): 272
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • La Roche-sur-Yon, France, 85925
    • Centre Hospitalier Departemental Vendee
  • Nantes, France, 44093
    • Centre Hospitalier Universitaire Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Administration of placebo; Administration of placebo in the margins of the episiotomy
Experimental: Ropivacaïne	Drug: Administration of Ropivacaïne; Administration of Ropivacaïne in the margins of the episiotomy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Departemental Vendee
• Investigators: Principal Investigator: Guillaume DUCARME, CHD Vendee

Publications and helpful links

General Publications

• Cardaillac C, Ploteau S, Le Thuaut A, Dochez V, Winer N, Ducarme G. Ropivacaine 75 mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair in postpartum women - the ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trials. Trials. 2020 Jun 12;21(1):522. doi: 10.1186/s13063-020-04423-x.
• Cardaillac C, Planche L, Dorion A, Ploteau S, Thubert T, Lefizelier E, Winer N, Ducarme G. Ropivacaine perineal infiltration for postpartum pain management in episiotomy repair: a double-blind, randomised, placebo-controlled trial. BJOG. 2024 Jun;131(7):899-907. doi: 10.1111/1471-0528.17266. Epub 2022 Aug 11.

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2017
• Primary Completion (Actual): November 4, 2020
• Study Completion (Actual): November 4, 2020

Study Registration Dates

• First Submitted: March 15, 2017
• First Submitted That Met QC Criteria: March 15, 2017
• First Posted (Actual): March 21, 2017

Study Record Updates

• Last Update Posted (Estimated): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: CHD065-16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No