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

NCT ID: NCT01323075

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-12-13

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Insufficiency Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Truncal block

Intervention Type PROCEDURE

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

Diabetic group

These patients have diabetes, but not renal insufficiency.

Truncal block

Intervention Type PROCEDURE

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

Non-exposed group

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

Truncal block

Intervention Type PROCEDURE

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

Interventions

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Truncal block

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

Intervention Type PROCEDURE

Eligibility Criteria

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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


* Patient has renal insufficiency as defined by a creatine clearance of \< 30ml/min without dialysis


* 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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe Cuvillon, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, France

Site Status

Hôpital Lapeyronnie CHU de Montpellier

Montpellier, , France

Site Status

Hôpital Privé Claude Galien

Quincy-sous-Sénart, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 29589414 (View on PubMed)

Other Identifiers

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LOCAL/2010/PC-02

Identifier Type: -

Identifier Source: org_study_id

2010-024519-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

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