Clinical trial NCT03084549: Study of the Analgesic Effect of the Perineal Infiltration of Ropivacaine 0.75% Versus Placebo in Post-episiotomy Perineal Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Episiotomy
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2017-03-21
Enrollment: 272
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 7 days after episiotomy
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche sur Yon
country: France
facility: Centre Hospitalier Departemental Vendee
city: Nantes
country: France
facility: Centre Hospitalier Universitaire Nantes
Study officials:
affiliation: CHD Vendée
name: Guillaume DUCARME
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.