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

4. august 2008 opdateret af: University Hospital, Angers

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

165

Fase

Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 50 år (Voksen)

Tager imod sunde frivillige

N/A

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Forebyggelse
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Dobbelt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Tidsramme
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 Tidsramme: 1 year	1 year

Sekundære resultatmål

Resultatmål	Tidsramme
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 Tidsramme: 24 hours	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 Tidsramme: 24 hours	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 Tidsramme: 24 hours	24 hours

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Angers

Efterforskere

Ledende efterforsker: Laurent Colbus, MD, Centre Hospitalier Universitaire Angers

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2006

Primær færdiggørelse (Faktiske)

1. juli 2007

Datoer for studieregistrering

Først indsendt

30. juli 2008

Først indsendt, der opfyldte QC-kriterier

1. august 2008

Først opslået (Skøn)

4. august 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. august 2008

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier