Skip to main content
OpenTrials
Completed

NCT Number: NCT01323075

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire de Nîmes, Nîmes, Gard, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Truncal block

Procedure

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

Primary outcomes

  1. The duration of sensory block in minutes.

    Time frame: Day 0 (per-op)

    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 outcomes

  1. Time necessary for completion of axillary blocks (1 / 3 upper humerus)(min)

    Time frame: Day 0 (per-op)

  2. Time necessary for installing sensory and motor block (min)

    Time frame: Day 0 (per-op)

    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

  3. Failure of the block: yes / no

    Time frame: Day 0 (per-op)

    Failure of the block: yes / no: defined by an absence of sensory block

  4. Presence of paresthesia: yes / no

    Time frame: Day 0 (per-op)

  5. Occurrence of neurological complications, yes/no

    Time frame: Day 0 (post-op)

    Neurological: occurrence of complications (paresthesia, paralysis, paresis ....) that persist (or not) until the final postoperative evaluation

  6. Occurrence of neurological complications, yes/no

    Time frame: 1 month

    Occurrence of neurological complications (paresthesia, paralysis, paresis ....)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 25, 2011
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.