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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01323075
First received: March 24, 2011
Last updated: April 25, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Renal Insufficiency
Diabetes
Procedure: Truncal block

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacodynamic Comparison of Truncal Blocks in Patients With or Without Metabolic Disease (Kidney Failure, Diabetes)

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • The duration of sensory block in minutes. [ Time Frame: Day 0 (per-op) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Time necessary for completion of axillary blocks (1 / 3 upper humerus)(min) [ Time Frame: Day 0 (per-op) ] [ Designated as safety issue: No ]
  • Time necessary for installing sensory and motor block (min) [ Time Frame: Day 0 (per-op) ] [ Designated as safety issue: No ]
    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 / no [ Time Frame: Day 0 (per-op) ] [ Designated as safety issue: No ]
    Failure of the block: yes / no: defined by an absence of sensory block

  • Presence of paresthesia: yes / no [ Time Frame: Day 0 (per-op) ] [ Designated as safety issue: No ]
  • Occurrence of neurological complications, yes/no [ Time Frame: Day 0 (post-op) ] [ Designated as safety issue: No ]
    Neurological: occurrence of complications (paresthesia, paralysis, paresis ....) that persist (or not) until the final postoperative evaluation

  • Occurrence of neurological complications, yes/no [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Occurrence of neurological complications (paresthesia, paralysis, paresis ....)


Enrollment: 120
Study Start Date: May 2011
Study Completion Date: December 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01323075

Locations
France
Centre Hospitalier Universitaire de Nîmes
Nîmes Cedex 09, Gard, France, 30029
Hôpital Lapeyronnie CHU de Montpellier
Montpellier Cedex 05, France, 34295
Hôpital Privé Claude Galien
Quincy-sous-Sénart, France, 91480
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Philippe Cuvillon, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01323075     History of Changes
Other Study ID Numbers: LOCAL/2010/PC-02, 2010-024519-15
Study First Received: March 24, 2011
Last Updated: April 25, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Diabetes Mellitus
Metabolic Diseases
Renal Insufficiency
Glucose Metabolism Disorders
Endocrine System Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 21, 2014