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

University Hospital, Angers

Status and phase

Completed

Phase 4

Conditions

Parturients

Childbirth

Treatments

Drug: Lidocaïne

Drug: Placebo

Drug: Ropivacaïne

Study type

Interventional

Funder types

Other

Identifiers

NCT00727935

CHU P 2006-03

Details and patient eligibility

About

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.

Enrollment

165 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Pre-inclusion criteria :

Assent of participation in the study signed
Major parturient (> 18 years) in the course of work in room of childbirth
Mono-foetal pregnancy
Presentation at the top

Inclusion Criteria:

Checking of the criteria of pre-inclusion
Oral confirmation of the assent of the patient
ASA 1 or 2
Childbirth by low way
Patient having an epidural analgesia
Patient having an episiotomy
Counter-indication with the ropivacaïne

Pre-exclusion criteria :

Absence of signed assent of participation in the study
Counter indication with the lidocaïne
General counter-indications suitable for the epidural anaesthesia , independently of the local anaesthetic used
Counter-indications with the infiltration: patient under anticoagulants, coagulopathy
Allergy to the lidocaine or the ropivacaine
Allergy to the one of analgesics per bones used in the assumption of responsibility of routine
Severe insufficiency hepatic and/or renal and/or ulcerates gastro-duodénal (in the case of anti-inflammatory drug regulation not steroid during the postpartum)
Minor
Major protected within the meaning of the law Huriet
Patient during one time of exclusion following another biomedical study

Exclusion Criteria:

Absence of oral confirmation of the assent of the patient
Infection or ignition of the point of puncture
Analgesia epidural not functional
Dural breach
Appearance of ascribable side effects to only the anaesthetic buildings at the time of epidural analgesia
Median Episiotomy (increased risk of lesions of the sphincter)
Need for an instrumentation at the time of expulsion
Haemorrhage of the delivery requiring a blood transfusion and/or general anaesthesia in urgency with surgical operation for haemostasis