ParturientsPhase 4LiRoPepNCT00727935
Comparison Of The Analgesia Obtained By Infiltration For The Joinings Of Episiotomies (Liropep)
A Phase 4 study testing Lidocaïne and Ropivacaïne in people with Parturients and Childbirth, run by University Hospital, Angers at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Parturients, Childbirth
- What is being tested?
- Lidocaïne and Ropivacaïne
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2006to Jul 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Adult
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire
Angers, Pays de la Loire Region, 49933
About this study
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
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
- Being tested
- Lidocaïne, Ropivacaïne, Placebo
- Keywords
- Women, parturients, with, realization, episiotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaïneDrug
RopivacaïneDrug
PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2008 (estimated)
- Study startOct 2006
- Primary completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParturientsStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Investigators
- Laurent Colbus, MD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00727935
- Sponsor's protocol ID
- CHU P 2006-03
- Acronym
- LiRoPep
- Status last verified
- Aug 2008
- First submitted
- 30 Jul 2008
- Last updated
- 5 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00727935
- Acronym / sponsor ID
- LiRoPep / CHU P 2006-03
- Conditions
- Parturients, Childbirth
- Keywords
- Women, parturients, with, realization, episiotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Oct 2006
- Primary completion
- Jul 2007 (actual)
- First posted
- 4 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaïne | Drug | – |
| Ropivacaïne | Drug | – |
| Placebo | Drug | – |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Colbus, MD principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaïne and Ropivacaïne in people with Parturients and Childbirth, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2008.