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

NCT01323075 | Completed

• 2 other identifiers: LOCAL/2010/PC-022010-024519-15
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Renal Insufficiency; Diabetes

Outcome Measures

Primary Outcomes (1)

• The duration of sensory block in minutes.

  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.

  Day 0 (per-op)

Secondary Outcomes (6)

• 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)

• Failure of the block: yes / no

  Day 0 (per-op)

• Presence of paresthesia: yes / no

  Day 0 (per-op)

• Occurrence of neurological complications, yes/no

  Day 0 (post-op)

Study Arms (3)

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.

Procedure: Truncal block

Diabetic group

These patients have diabetes, but not renal insufficiency.

Procedure: Truncal block

Non-exposed group

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

Procedure: Truncal block

Interventions

Truncal block PROCEDURE

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

Diabetic group; Non-exposed group; Renal insufficiency group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• The patient is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (3)

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, 30029, France

Location

Hôpital Lapeyronnie CHU de Montpellier

Montpellier, 34295, France

Location

Hôpital Privé Claude Galien

Quincy-sous-Sénart, 91480, France

Location

Related Publications (1)

• 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.

  PMID: 29589414 RESULT

MeSH Terms

Conditions

Renal Insufficiency; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Philippe Cuvillon, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: March 25, 2011
• Study Start: May 1, 2011
• Primary Completion: December 13, 2013
• Study Completion: December 13, 2013
• Last Updated: November 17, 2025

Record last verified: 2015-03

Locations

FR (3)