Pharmacodynamic Comparison of Truncal Blocks in Patients With or Without Metabolic Disease (Kidney Failure, Diabetes)
- Conditions
- Renal InsufficiencyDiabetes
- Interventions
- Procedure: Truncal block
- Registration Number
- NCT01323075
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Diabetic group Truncal block These patients have diabetes, but not renal insufficiency. Renal insufficiency group Truncal block 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. Non-exposed group Truncal block These patients have neither a neurological nor a metabolic disease and a creatine clearance of \> 90 ml/min
- Primary Outcome Measures
Name Time Method The duration of sensory block in minutes. Day 0 (per-op) 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.
- Secondary Outcome Measures
Name Time Method Time necessary for installing sensory and motor block (min) Day 0 (per-op) 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
Presence of paresthesia: yes / no Day 0 (per-op) Occurrence of neurological complications, yes/no 1 month Occurrence of neurological complications (paresthesia, paralysis, paresis ....)
Failure of the block: yes / no Day 0 (per-op) Failure of the block: yes / no: defined by an absence of sensory block
Time necessary for completion of axillary blocks (1 / 3 upper humerus)(min) Day 0 (per-op)
Trial Locations
- Locations (3)
Hôpital Lapeyronnie CHU de Montpellier
🇫🇷Montpellier Cedex 05, France
Centre Hospitalier Universitaire de Nîmes
🇫🇷Nîmes Cedex 09, Gard, France
Hôpital Privé Claude Galien
🇫🇷Quincy-sous-Sénart, France