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 (LiRoPep)

NCT00727935 Phase 4 COMPLETED

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.

Details

Lead sponsor	University Hospital, Angers
Phase	Phase 4
Status	COMPLETED
Enrolment	165
Start date	2006-10

Conditions

• Parturients
• Childbirth

Interventions

• Lidocaïne
• Ropivacaïne
• Placebo

Primary outcomes

• Time between the infiltration of the local anaesthetic and the first analgesics catch per os, which is managed when the level of pain evaluated by EVA is higher than 30 mm — 1 year

Countries

France