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

Purpose

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.

Condition	Intervention	Phase
Parturients Childbirth	Drug: Lidocaïne Drug: Ropivacaïne Drug: Placebo	Phase IV

MedlinePlus related topics:

Anesthesia

ChemIDplus related topics:

Ropivacaine Ropivacaine Hydrochloride Ropivacaine monohydrochloride Lidocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment

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

Further study details as provided by University Hospital, Angers:

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 ]

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 ]

Enrollment:	165
Study Start Date:	October 2006
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00727935

Locations


France, Pays-de-la-Loire
	Centre Hospitalier Universitaire
	Angers, Pays-de-la-Loire, France, 49933

Sponsors and Collaborators

University Hospital, Angers

Investigators


Principal Investigator:	Laurent Colbus, MD	Centre Hospitalier Universitaire Angers

More Information

Study ID Numbers:	CHU P 2006-03
First Received:	July 30, 2008
Last Updated:	August 4, 2008
ClinicalTrials.gov Identifier:	NCT00727935
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Angers:

Women

parturients

with

realization

episiotomy

Study placed in the following topic categories:

Ropivacaine

Lidocaine

Additional relevant MeSH terms:

Sensory System Agents

Therapeutic Uses

Physiological Effects of Drugs

Central Nervous System Depressants

Anesthetics

Cardiovascular Agents

Anti-Arrhythmia Agents

Peripheral Nervous System Agents

Central Nervous System Agents

Pharmacologic Actions

Anesthetics, Local

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	University Hospital, Angers
Information provided by:	University Hospital, Angers
ClinicalTrials.gov Identifier:	NCT00727935