Pharmacodynamic Comparison of Truncal Blocks in Patients With or Without Metabolic Disease (Kidne… (NCT01323075) | Clinical Trial Compass
CompletedNot Applicable
Pharmacodynamic Comparison of Truncal Blocks in Patients With or Without Metabolic Disease (Kidney Failure, Diabetes)
France120 participantsStarted 2011-05
Plain-language summary
The primary objective is to demonstrate a longer period of neurologic recovery from a sensory block assessed in each test group versus the group without metabolic disease.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
General Inclusion Criteria:
* The patient must have given his/her informed and signed consent
* 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
Inclusion Criteria for the "Renal Insufficiency" group
* Patient has renal insufficiency as defined by a creatine clearance of \< 30ml/min without dialysis
Inclusion Criteria for the "Diabetes" group
* 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
Inclusion Criteria for the "Non-exposed" group
* Patient without metabolic or neurologic disease, with creating clearance \> 90ml/min
Exclusion Criteria:
* The patient is participating in another study
* 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 M…