Clinical Trials Directory

Trials / Completed

CompletedNCT00727935

Comparison Of The Analgesia Obtained By Infiltration For The Joinings Of Episiotomies (Liropep)

Comparison Of The Analgesia Obtained By Infiltration Of Lidocaïne 1% And Ropivacaïne 0,75% Versus Placebo For The Joinings Of Episiotomies Among Parturients Under Epidural Analgesia

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
165 (actual)
Sponsor
University Hospital, Angers · Other Government
Sex
Female
Age
18 Years – 50 Years
Healthy volunteers

Summary

Lateral episiotomy is a current care practiced with childbirth room. One of the problems encountered with this surgical act is the residual pain on perineal scar level. Maximal during the first 24 hours, this pain can persist several days or several weeks hampering to variable degrees a normal recovery of autonomy and comfort of life. Some studies have shown the interest of ropivacaine, local anaesthetic with a long action's duration for proctologic surgeries and for the cure of inguinal hernia. A recent study shown the ropivacaine perineal infiltration used prior perineorrhaphy allows an absence of post-partum pain for 24 to 27% of cases and a first analgesics request delayed to ten hours. Methodology: 165 parturients having an epidural analgesia and an episiotomy were enrolled. The perineal infiltration was randomized according to 3 equal groups (placebo, ropivacaine 0,75%, lidocaine 1%) and realised prior perineorrhaphy. then The parturient were followed during the 24 first hours. This study was designed as double blind and the study conduct was standardized in order to get only variable such as the episiotomy infiltration.

Conditions

Interventions

TypeNameDescription
DRUGLidocaïne
DRUGRopivacaïne
DRUGPlacebo

Timeline

Start date
2006-10-01
Primary completion
2007-07-01
First posted
2008-08-04
Last updated
2008-08-05

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT00727935. Inclusion in this directory is not an endorsement.