Clinical trial NCT01323075: Pharmacodynamic Comparison of Truncal Blocks in Patients With or Without Metabolic Disease (Kidney Failure, Diabetes)
Official title: Pharmacodynamic Comparison of Truncal Blocks in Patients With or Without Metabolic Disease (Kidney Failure, Diabetes)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Insufficiency
Diabetes
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2011-03-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility 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

Primary outcomes:
measure: The duration of sensory block in minutes.
timeFrame: Day 0 (per-op)
Secondary outcomes:
measure: Time necessary for completion of axillary blocks (1 / 3 upper humerus)(min)
timeFrame: Day 0 (per-op)
measure: Time necessary for installing sensory and motor block (min)
timeFrame: Day 0 (per-op)
measure: Failure of the block: yes / no
timeFrame: Day 0 (per-op)
measure: Presence of paresthesia: yes / no
timeFrame: Day 0 (per-op)
measure: Occurrence of neurological complications, yes/no
timeFrame: Day 0 (post-op)
measure: Occurrence of neurological complications, yes/no
timeFrame: 1 month
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: Centre Hospitalier Universitaire de Nîmes
state: Gard
city: Montpellier Cedex 05
country: France
facility: Hôpital Lapeyronnie CHU de Montpellier
city: Quincy-sous-Sénart
country: France
facility: Hôpital Privé Claude Galien
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Philippe Cuvillon, MD
role: PRINCIPAL_INVESTIGATOR
References: