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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

272 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-24

Study Completion Date

2020-11-04

Brief Summary

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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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Detailed Description

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Conditions

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Episiotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ropivacaïne

Group Type EXPERIMENTAL

Administration of Ropivacaïne

Intervention Type DRUG

Administration of Ropivacaïne in the margins of the episiotomy

Placebo

Group Type PLACEBO_COMPARATOR

Administration of placebo

Intervention Type DRUG

Administration of placebo in the margins of the episiotomy

Interventions

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Administration of Ropivacaïne

Administration of Ropivacaïne in the margins of the episiotomy

Intervention Type DRUG

Administration of placebo

Administration of placebo in the margins of the episiotomy

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No