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

Centre Hospitalier Departemental Vendee

Status and phase: Completed; Phase 3

Conditions: Episiotomy

Treatments: Drug: Administration of placebo; Drug: Administration of Ropivacaïne

Study type: Interventional

Funder types: Other

Identifiers

NCT03084549

CHD065-16

Details and patient eligibility

About

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.

Enrollment: 272 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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272 participants in 2 patient groups, including a placebo group

Ropivacaïne

Experimental group

Treatment:

Drug: Administration of Ropivacaïne

Placebo

Placebo Comparator group

Treatment:

Drug: Administration of placebo