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

Episiotomy Clinical Trial

— ROPISIO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03084549
• Other study ID #: CHD065-16
• Status: Completed
• Phase: Phase 3
• Start date: October 24, 2017
• Est. completion date: November 4, 2020

Study information

• Verified date: January 2021
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: November 4, 2020
• Est. primary completion date: November 4, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Episiotomy

Intervention

Drug:
• Administration of Ropivacaïne
Administration of Ropivacaïne in the margins of the episiotomy
• Administration of placebo
Administration of placebo in the margins of the episiotomy

Locations

Country	Name	City	State
France	Centre Hospitalier Departemental Vendee	La Roche sur Yon
France	Centre Hospitalier Universitaire Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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