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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01323075
Enrollment
120
Registered
2011-03-25
Start date
2011-05-31
Completion date
2013-12-13
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, 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.

Interventions

PROCEDURETruncal block

Patients will have a truncal block during hand or wrist surgery.

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Occurrence of neurological complications, yes/noDay 0 (post-op)Neurological: occurrence of complications (paresthesia, paralysis, paresis ....) that persist (or not) until the final postoperative evaluation
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)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
Failure of the block: yes / noDay 0 (per-op)Failure of the block: yes / no: defined by an absence of sensory block
Presence of paresthesia: yes / noDay 0 (per-op)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026