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

NCT00727935 | Completed Phase 4 DMC

• 1 other identifier: CHU P 2006-03
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Parturients; Childbirth

Keywords

Women; parturients; with; realization; episiotomy

Outcome Measures

Primary Outcomes (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

  1 year

Secondary Outcomes (3)

• 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

Interventions

Lidocaïne DRUG

Ropivacaïne DRUG

Placebo DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Centre Hospitalier Universitaire

Angers, Pays de la Loire Region, 49933, France

Location

Study Officials

• Laurent Colbus, MD

  Centre Hospitalier Universitaire Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 30, 2008
• First Posted: August 4, 2008
• Study Start: October 1, 2006
• Primary Completion: July 1, 2007
• Last Updated: August 5, 2008

Record last verified: 2008-08

Locations

FR (1)