EpisiotomyPhase 3ROPISIONCT03084549
Study of the Analgesic Effect of the Perineal Infiltration of Ropivacaine 0.75% Versus Placebo in Post-episiotomy Perineal Pain
A Phase 3 study testing Administration of Ropivacaïne in people with Episiotomy, run by Centre Hospitalier Departemental Vendee at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Episiotomy
- What is being tested?
- Administration of Ropivacaïne
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 272 participants
- Where
- 2 sitesFrance
- Study dates
- 24 Oct 2017to 4 Nov 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Patient in ability to understand protocol
- Patient having given consent and signed informed consent
- Patient with social coverage
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Departemental Vendee
La Roche-sur-Yon, 85925
Centre Hospitalier Universitaire Nantes
Nantes, 44093
About this study
Official 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
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.
- Conditions
- Episiotomy
- Being tested
- Administration of Ropivacaïne, Administration of placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of RopivacaïneDrug
Administration of Ropivacaïne in the margins of the episiotomy
Administration of placeboDrug
Administration of placebo in the margins of the episiotomy
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaïne | Experimental | Not described Receives: Drug: Administration of Ropivacaïne |
| Placebo | Placebo comparator | Not described Receives: Drug: Administration of placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days after episiotomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start24 Oct 2017
- Primary completion4 Nov 2020
- Study completion4 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EpisiotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume DUCARME, Principal investigator, CHD Vendée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084549
- Sponsor's protocol ID
- CHD065-16
- Acronym
- ROPISIO
- Status last verified
- Nov 2025
- First submitted
- 15 Mar 2017
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 32532310Cardaillac 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.
PubMed 35876236
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03084549
- Acronym / sponsor ID
- ROPISIO / CHD065-16
- Conditions
- Episiotomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 4 Nov 2020 (actual)
- Study completion
- 4 Nov 2020 (actual)
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaïne | Experimental | Drug: Administration of Ropivacaïne |
| Placebo | Placebo comparator | Drug: Administration of placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of RopivacaïneAdministration of Ropivacaïne in the margins of the episiotomy | Drug | Ropivacaïne |
| Administration of placeboAdministration of placebo in the margins of the episiotomy | Drug | Placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Background: PubMed 32532310Cardaillac 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.
- Results publication: PubMed 35876236Cardaillac 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume DUCARME principal investigator
CHD Vendée
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Administration of Ropivacaïne in people with Episiotomy, run by Centre Hospitalier Departemental Vendee at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03084549, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.