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

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.

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Key information

Conditions

Episiotomy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Centre Hospitalier Departemental Vendee, La Roche-sur-Yon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Administration of Ropivacaïne

Drug

Administration of Ropivacaïne in the margins of the episiotomy

Administration of placebo

Drug

Administration of placebo in the margins of the episiotomy

Primary outcomes

Compare the analgesic efficacy of ropivacaine 75 mg infusion versus placebo (physiological saline) in patients with right mid-lateral episiotomy during postpartum D7 delivery.

Time frame: 7 days after episiotomy

Digital pain scale

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Departemental Vendee

Other

Registry information

Official study title

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

Acronym: ROPISIO

Important dates

Study start: 2017
Primary completion: 2020
Study completion: 2020
First posted: Mar 21, 2017
Registry last updated: Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed