NCT03084549

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
272

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2017

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

October 24, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2020

Completed
Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

3 years

First QC Date

March 15, 2017

Last Update Submit

November 14, 2025

Conditions

Episiotomy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Ropivacaïne

EXPERIMENTAL
Drug: Administration of Ropivacaïne

Placebo

PLACEBO COMPARATOR
Drug: Administration of placebo

Interventions

Administration of RopivacaïneDRUG

Administration of Ropivacaïne in the margins of the episiotomy

Ropivacaïne
Administration of placeboDRUG

Administration of placebo in the margins of the episiotomy

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Departemental Vendee

La Roche-sur-Yon, 85925, France

Location

Centre Hospitalier Universitaire Nantes

Nantes, 44093, France

Location

Related Publications (2)

  • 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.

    PMID: 32532310BACKGROUND

  • 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.

    PMID: 35876236RESULT

Study Officials

  • Guillaume DUCARME

    CHD Vendée

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2017

First Posted

March 21, 2017

Study Start

October 24, 2017

Primary Completion

November 4, 2020

Study Completion

November 4, 2020

Last Updated

November 17, 2025

Record last verified: 2025-11

Locations

FR(2)