Status:
COMPLETED
Comparison Of The Analgesia Obtained By Infiltration For The Joinings Of Episiotomies (Liropep)
Lead Sponsor:
University Hospital, Angers
Conditions:
Parturients
Childbirth
Eligibility:
FEMALE
18-50 years
Phase:
PHASE4
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 hou...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00727935
Start Date
October 1 2006
Last Update
August 5 2008
Active Locations (1)
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1
Centre Hospitalier Universitaire
Angers, Pays de la Loire Region, France, 49933