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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00727935
Recruitment Status : Completed
First Posted : August 4, 2008
Last Update Posted : August 5, 2008
Information provided by:
University Hospital, Angers

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.

Condition or disease Intervention/treatment Phase
Parturients Childbirth Drug: Lidocaïne Drug: Ropivacaïne Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
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 Start Date : October 2006
Actual Primary Completion Date : July 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Lidocaine
U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]
  3. 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 ]

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00727935

Centre Hospitalier Universitaire
Angers, Pays-de-la-Loire, France, 49933
Sponsors and Collaborators
University Hospital, Angers
Principal Investigator: Laurent Colbus, MD Centre Hospitalier Universitaire Angers Identifier: NCT00727935     History of Changes
Other Study ID Numbers: CHU P 2006-03
First Posted: August 4, 2008    Key Record Dates
Last Update Posted: August 5, 2008
Last Verified: August 2008

Keywords provided by University Hospital, Angers:

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action