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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Renal Insufficiency
• Intervention / Treatment: Procedure: Truncal block

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• France
  • Montpellier Cedex 05, France, 34295
    • Hôpital Lapeyronnie CHU de Montpellier
  • Quincy-sous-Sénart, France, 91480
    • Hôpital Privé Claude Galien
  • Gard
    • Nîmes Cedex 09, Gard, France, 30029
      • Centre Hospitalier Universitaire de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Patients will have a truncal block during hand or wrist surgery.
Diabetic group; These patients have diabetes, but not renal insufficiency.	Procedure: Truncal block; 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	Procedure: Truncal block; Patients will have a truncal block during hand or wrist surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	Day 0 (per-op)
Failure of the block: yes / no	Failure of the block: yes / no: defined by an absence of sensory block	Day 0 (per-op)
Presence of paresthesia: yes / no		Day 0 (per-op)
Occurrence of neurological complications, yes/no	Neurological: occurrence of complications (paresthesia, paralysis, paresis ....) that persist (or not) until the final postoperative evaluation	Day 0 (post-op)
Occurrence of neurological complications, yes/no	Occurrence of neurological complications (paresthesia, paralysis, paresis ....)	1 month

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Philippe Cuvillon, MD, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: March 24, 2011
• First Submitted That Met QC Criteria: March 24, 2011
• First Posted (Estimate): March 25, 2011

Study Record Updates

• Last Update Posted (Estimate): March 26, 2015
• Last Update Submitted That Met QC Criteria: March 25, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Diabetes Mellitus; Renal Insufficiency; Metabolic Diseases
• Other Study ID Numbers: LOCAL/2010/PC-02; 2010-024519-15 (EudraCT Number)