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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024519-15 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Diabetic group | These patients have diabetes, but not renal insufficiency. |
| |
| Non-exposed group | These patients have neither a neurological nor a metabolic disease and a creatine clearance of > 90 ml/min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Truncal block | Procedure | Patients will have a truncal block during hand or wrist surgery. |
|
| 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) |
| 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 |
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General Inclusion Criteria:
Inclusion Criteria for the "Renal Insufficiency" group
Inclusion Criteria for the "Diabetes" group
Inclusion Criteria for the "Non-exposed" group
Exclusion Criteria:
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Three patient populations schelduled for surgery on the hand or wrist. The three groups include (1) patients with no metabolic or neurologic disease history, (2) patients with renal insufficiency but not diabetes and (3) patients with diabetes but not renal insufficiency.
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Cuvillon, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Nîmes | Nîmes | Gard | 30029 | France | ||
| Hôpital Lapeyronnie CHU de Montpellier |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29589414 | Result | 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. |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 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 |
| Montpellier |
| 34295 |
| France |
| Hôpital Privé Claude Galien | Quincy-sous-Sénart | 91480 | France |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |