Pharmacodynamic Comparison of Truncal Blocks in Patients With or Without Metabolic Disease (Kidney Failure, Diabetes)
NCT ID: NCT01323075
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
120 participants
OBSERVATIONAL
2011-05-31
2013-12-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Renal insufficiency group
Patients in this group have renal insufficiency as defined by a creatinine clearance of \< 30 ml/min without dialysis. These patients do not have diabetes.
Truncal block
Patients will have a truncal block during hand or wrist surgery.
Diabetic group
These patients have diabetes, but not renal insufficiency.
Truncal block
Patients will have a truncal block during hand or wrist surgery.
Non-exposed group
These patients have neither a neurological nor a metabolic disease and a creatine clearance of \> 90 ml/min
Truncal block
Patients will have a truncal block during hand or wrist surgery.
Interventions
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Truncal block
Patients will have a truncal block during hand or wrist surgery.
Eligibility Criteria
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Inclusion Criteria
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 1 month of follow up
* The patient is scheduled for hand or wrist surgery
* Patient has renal insufficiency as defined by a creatine clearance of \< 30ml/min without dialysis
* Patient has chronic hyperglycemia, either a fasting glycemia \> 1.26 g/l (7mmol/l) for longer than 5 years and receiving an oral, well-adjusted (last HBA1c \< 6.5%)), non-insulin, antidiabetic treatment
* Patient without metabolic or neurologic disease, with creating clearance \> 90ml/min
Exclusion Criteria
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant
* The patient is breastfeeding
* Patient weighs less than 50 kg
* Score ASA \> 4
* contra indication for locoregional anesthesia
* Severe metabolic and / or decompensated renal disease, cardiac or pulmonary decompensation
* Associated peripheral neuropathy associated with diabetes or kidney disease
* Associated central neuropathy associated (eg MS ... narrow cervical canal)
* Patients with both renal failure and diabetes
18 Years
80 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Principal Investigators
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Philippe Cuvillon, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Nîmes
Locations
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Centre Hospitalier Universitaire de Nîmes
Nîmes, Gard, France
Hôpital Lapeyronnie CHU de Montpellier
Montpellier, , France
Hôpital Privé Claude Galien
Quincy-sous-Sénart, , France
Countries
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References
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Cuvillon P, Casier M, Demattei C, Bernard N, Boisson C, Vialles N, Lhermite J, Ripart J, Capdevila X. Comparison of axillary nerve block duration using mepivacaine in non-insulin diabetic or renal insufficiency patients: a controlled observational matched multicenter trial. Minerva Anestesiol. 2019 Feb;85(2):124-132. doi: 10.23736/S0375-9393.18.12322-4. Epub 2018 Mar 27.
Other Identifiers
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LOCAL/2010/PC-02
Identifier Type: -
Identifier Source: org_study_id
2010-024519-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
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