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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Diabetes; Renal Insufficiency

Treatments: Procedure: Truncal block

Study type: Observational

Funder types: Other

Identifiers

NCT01323075

2010-024519-15 (EudraCT Number)

LOCAL/2010/PC-02

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

120 participants in 3 patient groups

Renal insufficiency group

Description:

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.

Treatment:

Procedure: Truncal block

Diabetic group

Description:

These patients have diabetes, but not renal insufficiency.

Treatment:

Procedure: Truncal block

Non-exposed group

Description:

These patients have neither a neurological nor a metabolic disease and a creatine clearance of \> 90 ml/min

Treatment:

Procedure: Truncal block