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.
Procedure: Truncal block
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01323075
Ages eligible for Study
18 Years to 80 Years
Genders eligible for Study
Accepts Healthy Volunteers
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
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 MS ... narrow cervical canal)
Patients with both renal failure and diabetes
All locations for NCT01323075
Centre Hospitalier Universitaire de Nîmes
Nîmes Cedex 09, Gard, France, 30029
Hôpital Lapeyronnie CHU de Montpellier
Montpellier Cedex 05, France, 34295
Hôpital Privé Claude Galien
Quincy-sous-Sénart, France, 91480
View full eligibility
Tris trial is registered with FDA with number: NCT01323075. The sponsor of the trial is Centre Hospitalier Universitaire de Nīmes and it is looking for 120 volunteers for the current phase.
Official trial title: Pharmacodynamic Comparison of Truncal Blocks in Patients With or Without Metabolic Disease (Kidney Failure, Diabetes)
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