Surgical Pathology of the Leg or the Foot.Phase 3NCT00682344
Pharmacokinetic of levobupivacaïne After Sciatic Nerve Block in Children
A Phase 3 study testing Levobupivacaïne in people with Surgical Pathology of the Leg or the Foot., run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Levobupivacaïne (Chirocaine®) is a new local anaesthetic recently marketed in France. The goal of this prospective work is to study the pharmacokinetic aspect of this drug after injection around the sciatic nerve (subgluteal way). Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Surgical Pathology of the Leg or the Foot.
- What is being tested?
- Levobupivacaïne
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2008to Jan 2012
- Phase
- Phase 3
- 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 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Surgical pathology of the leg or the foot with garot tyre of thigh
- Age included between 6 months and 12 years
- Status ASA I or II
Who cannot join
- Bilateral or one-sided surgical gesture realized without garot tyre
- Cutaneous infection in the point of draining
- Clinical confusion of the coagulation
- Allergy informed in the local anesthesics of amino-acid class
- Evolutionary neurological pathology of the operated limb
- Renal, respiratory, cardiac or hepatic insufficiency.
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital de la Timone - Pôle d'anesthésie réanimation pédiatrique
Marseille, 13005
About this study
Levobupivacaïne (Chirocaine®) is a new local anaesthetic recently marketed in France. The goal of this prospective work is to study the pharmacokinetic aspect of this drug after injection around the sciatic nerve (subgluteal way).
Read the detailed description
The originality of this work is to call upon a modelling of pharmacokinetic by using the principle of the pharmacology of population.
This work also proposes to appreciate a dynamic aspect since data of effectiveness and tolerance will be collected with regular intervals during the first 24 hours after the beginning of the study.
- Being tested
- Levobupivacaïne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaïneDrug
1,75mg/kg
What is being measured
The primary outcome is the main question the study is designed to answer.
The purpose of this work is to describe the pharmacokinetics characteristics by the levobupivacaine after peripheral block by using the principle of the pharmacology of population, this allowing fewer sampling of blood by patients.
Measured: 24 months
Secondary outcomes (1)
Appreciation, by the anaesthetist in charge of the patient, of the quality of the "surgical" analgesia during the surgery by: very effective, effective, ineffective. Measure of the delay of appeal of the first one bolus of morphine.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Pathology of the Leg or the Foot.Studies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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 3
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric LACROIX, MD, Principal investigator, ASSISTANCE PUBLIQUE DES HOPITAUX DE MARSEILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682344
- Sponsor's protocol ID
- 2007-000796-42
- Other IDs
- 2007-08
- Status last verified
- Aug 2014
- First submitted
- 16 May 2008
- Last updated
- 28 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic of levobupivacaïne After Sciatic Nerve Block in Children
- ClinicalTrials.gov ID
- NCT00682344
- Acronym / sponsor ID
- 2007-000796-42
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 22 May 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.
Levobupivacaïne (Chirocaine®) is a new local anaesthetic recently marketed in France. The goal of this prospective work is to study the pharmacokinetic aspect of this drug after injection around the sciatic nerve (subgluteal way).
Detailed description
The originality of this work is to call upon a modelling of pharmacokinetic by using the principle of the pharmacology of population.
This work also proposes to appreciate a dynamic aspect since data of effectiveness and tolerance will be collected with regular intervals during the first 24 hours after the beginning of the study.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Surgical pathology of the leg or the foot with garot tyre of thigh
- Age included between 6 months and 12 years
- Status ASA I or II
Key exclusion criteria (6 listed)
- Bilateral or one-sided surgical gesture realized without garot tyre
- Cutaneous infection in the point of draining
- Clinical confusion of the coagulation
- Allergy informed in the local anesthesics of amino-acid class
- Evolutionary neurological pathology of the operated limb
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 |
|---|---|---|
| Levobupivacaïne1,75mg/kg | Drug | – |
Primary outcome
The purpose of this work is to describe the pharmacokinetics characteristics by the levobupivacaine after peripheral block by using the principle of the pharmacology of population, this allowing fewer sampling of blood by patients.
Time frame: 24 months
1 secondary outcome
Appreciation, by the anaesthetist in charge of the patient, of the quality of the "surgical" analgesia during the surgery by: very effective, effective, ineffective. Measure of the delay of appeal of the first one bolus of morphine.
Time frame: 24 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2014.
Related trials for Surgical Pathology of the Leg or the Foot.
RecruitingObservational study
Systemic Biochemical Signature and Functional Quality Index of Calcaneal Bone Marrow Aspirate in Adults Undergoing Foot or Ankle Surgery
Diabetic Foot Ulcer, Wound Healing
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.
Frédéric LACROIX, MD principal investigator
ASSISTANCE PUBLIQUE DES HOPITAUX DE MARSEILLE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levobupivacaïne in people with Surgical Pathology of the Leg or the Foot., run by Assistance Publique Hopitaux De Marseille 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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 28 Aug 2014. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early. Results are not available in the source record.
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?
The purpose of this work is to describe the pharmacokinetics characteristics by the levobupivacaine after peripheral block by using the principle of the pharmacology of population, this allowing fewer sampling of blood by patients. (time frame: 24 months). 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 28 Aug 2014.