Pharmacodynamic Comparison of Truncal Blocks in Patients With or Without Metabolic Disease (Kidney Failure, Diabetes)

Study Overview
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Brief Summary
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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.

Official Title
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Pharmacodynamic Comparison of Truncal Blocks in Patients With or Without Metabolic Disease (Kidney Failure, Diabetes)

Conditions
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Renal Insufficiency, Diabetes

Intervention / Treatment
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* Procedure: Truncal block


Participation Criteria
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Eligibility Criteria
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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 MS ... narrow cervical canal) Patients with both renal failure and diabetes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Renal insufficiency group<br>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. | Procedure: Truncal block<br>* Patients will have a truncal block during hand or wrist surgery.<br>|
| Diabetic group<br>These patients have diabetes, but not renal insufficiency. | Procedure: Truncal block<br>* Patients will have a truncal block during hand or wrist surgery.<br>|
| Non-exposed group<br>These patients have neither a neurological nor a metabolic disease and a creatine clearance of > 90 ml/min | Procedure: Truncal block<br>* Patients will have a truncal block during hand or wrist surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration of sensory block in minutes. | The duration of the sensory block in minutes. The beginning of this term is defined by the end of the axillary block (last injection), and the end of this period is defined by the reappearance of sensitivity to touch in the area anesthetized. | Day 0 (per-op) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time necessary for completion of axillary blocks (1 / 3 upper humerus)(min) |  | Day 0 (per-op) | 
| Time necessary for installing sensory and motor block (min) | Time necessary for installing sensory and motor block (min): defined by the delay between the end of the block injection and the occurrence of insensitivity of blocked territories | Day 0 (per-op) | 
| Failure of the block: yes / no | Failure of the block: yes / no: defined by an absence of sensory block | Day 0 (per-op) | 
| Presence of paresthesia: yes / no |  | Day 0 (per-op) | 
| Occurrence of neurological complications, yes/no | Neurological: occurrence of complications (paresthesia, paralysis, paresis ....) that persist (or not) until the final postoperative evaluation | Day 0 (post-op) | 
| Occurrence of neurological complications, yes/no | Occurrence of neurological complications (paresthesia, paralysis, paresis ....) | 1 month |