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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01323075
• Other study ID #: LOCAL/2010/PC-02
• Secondary ID: 2010-024519-15
• Status: Completed
• Phase: N/A
• First received: March 24, 2011
• Last updated: March 25, 2015
• Start date: May 2011
• Est. completion date: December 2013

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Metabolic Diseases
• Renal Insufficiency

Intervention

Procedure:
• Truncal block
Patients will have a truncal block during hand or wrist surgery.

Locations

Country	Name	City	State
France	Hôpital Lapeyronnie CHU de Montpellier	Montpellier Cedex 05
France	Centre Hospitalier Universitaire de Nîmes	Nîmes Cedex 09	Gard
France	Hôpital Privé Claude Galien	Quincy-sous-Sénart

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Time necessary for completion of axillary blocks (1 / 3 upper humerus)(min)		Day 0 (per-op)	No
Secondary	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)	No
Secondary	Failure of the block: yes / no	Failure of the block: yes / no: defined by an absence of sensory block	Day 0 (per-op)	No
Secondary	Presence of paresthesia: yes / no		Day 0 (per-op)	No
Secondary	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)	No
Secondary	Occurrence of neurological complications, yes/no	Occurrence of neurological complications (paresthesia, paralysis, paresis ....)	1 month	No