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

Episiotomy Clinical Trial

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 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03084549
Study type Interventional
Source Centre Hospitalier Departemental Vendee
Contact
Status Completed
Phase Phase 3
Start date October 24, 2017
Completion date November 4, 2020
View Details
See also
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