Clinical trial NCT00727935: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parturients
Childbirth
Keywords: Women
parturients
with
realization
episiotomy
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2008-08-04
Enrollment: 165
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: 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
timeFrame: 1 year
Secondary outcomes:
measure: 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
timeFrame: 24 hours
measure: To compare between the 3 groups the analgesics overall consumption per os during the first 24 hours following the joining of the episiotomy
timeFrame: 24 hours
measure: 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
timeFrame: 24 hours
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Hospitalier Universitaire
state: Pays-de-la-Loire
Study officials:
affiliation: Centre Hospitalier Universitaire Angers
name: Laurent Colbus, MD
role: PRINCIPAL_INVESTIGATOR
References: