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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 30, 2008

Last Updated Date

August 4, 2008

Start Date ^†

October 2006

Current Primary Outcome Measures ^†

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 [ Time Frame: 1 year ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00727935 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

To compare between the 3 groups the mean level of the pain during the first 24 hours following the joining of the episiotomy, measured by EVA [ Time Frame: 24 hours ]
To compare between the 3 groups the analgesics overall consumption per os during the first 24 hours following the joining of the episiotomy [ Time Frame: 24 hours ]
To compare between the 3 groups the total cost of the analgesics consumption (local anaesthetic employed and analgesics per bone) during the first 24 hours following the joining of the episiotomy [ Time Frame: 24 hours ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

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.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Condition ^†

Parturients
Childbirth

Intervention ^†

Drug: Lidocaïne
Drug: Ropivacaïne
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

165

Completion Date

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Female

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

France

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00727935

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

University Hospital, Angers

Collaborators ^††

Investigators ^†

Principal Investigator:

Laurent Colbus, MD

Centre Hospitalier Universitaire Angers

Information Provided By

University Hospital, Angers

Verification Date

August 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.