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

NCT ID: NCT00727935

Last Updated: 2008-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31

Brief 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

Parturients; Childbirth

Keywords

Women; parturients; with; realization; episiotomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

Lidocaïne

Intervention Type: DRUG

Ropivacaïne

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• 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

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Laurent Colbus, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Angers

Locations

Centre Hospitalier Universitaire

Angers, Pays de la Loire Region, France

Countries

France

Other Identifiers

CHU P 2006-03

Identifier Type: -

Identifier Source: org_study_id