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

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.

Study Overview

• Status: Completed
• Conditions: Parturients; Childbirth
• Intervention / Treatment: Drug: Placebo; Drug: Lidocaïne; Drug: Ropivacaïne

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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	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	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	24 hours

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Laurent Colbus, MD, Centre Hospitalier Universitaire Angers

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: July 30, 2008
• First Submitted That Met QC Criteria: August 1, 2008
• First Posted (Estimate): August 4, 2008

Study Record Updates

• Last Update Posted (Estimate): August 5, 2008
• Last Update Submitted That Met QC Criteria: August 4, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: Women; episiotomy; parturients; with; realization
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Ropivacaine
• Other Study ID Numbers: CHU P 2006-03