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CompletedNCT03290404fLACONUpdated Apr 6, 2018

Descriptive Assessment of Practice in Anaesthesia : Lidocaine 1% Adrenaline Under in Axillary Block Realization

An observational study in Axillary Block, sponsored by University Hospital, Brest. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-06.

Sponsored by University Hospital, Brest · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
292
Ages
18 Years and older
Sex
All
01

Study summary

Axillary block is the good anesthetic technique for upper limb surgery without exceeding a certain total dose injected of Local Anesthetic (AL).

The maximal recommended dose of Lidocaine adrenaline in the upper limb is 500 mg. The use of ultrasound helps guiding the locoregional anesthesia, and allows to decrease the AL concentration, thus decreasing the risks.

No previous study estimated a concentration of lidocaine lower than 1,5 % to realize upper limb surgery by axillary block.

The literature overestimating probably the rate of failure of the locoregional anesthesia under ultrasound-guidance, we suggest to estimate the rate of failure of the axillary block ultrasound-guided with the lidocaine 1 % adrenaline for realizing upper limb surgery in standard practice.

02

Conditions studied

  • Axillary Block

Keywords

  • Axillary Block
  • LidocaÏne 1% adrenaliné
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult operated for the upper limb under block axillaire

Inclusion criteria

  • Patients operated for the upper limb under block axillaire
  • Adult
  • non-opposition

Exclusion criteria

Exclusion Criteria:

  • medical advice to realize axillary block
  • medical advice to local anaesthetic
  • Allergy
  • Pregnant
  • ASA 3 or more
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
292 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Resort to an anesthesia for help in case of ineffectiveness of the block

    Yes or no Yes or No

    Time frame: Day 1

Secondary outcomes

  1. Block depth

    Bromage score

    Time frame: Day 1

Other outcomes

  1. Time of Block

    Minutes

    Time frame: Day 1

  2. Total dose of Lidocaïne adrenaline used

    mg

    Time frame: Day 1

  3. Patient satisfaction

    questionnaire score

    Time frame: Day 1

06

Study locations

3 sites
  • Hôpital Instruction des Armées
    Brest, 29200, France
  • CHRU de Brest
    Brest, 29609, France
  • Centre Hospitalier Intercommunal de Cornouaille
    Quimper, 29017, France
07

Registry details

Key details

Study ID
NCT03290404
Lead sponsor
University Hospital, Brest
Responsible party
Sponsor
First posted
Sep 21, 2017
Start date
Nov 13, 2017
Primary completion
Mar 19, 2018
Completion
Mar 19, 2018
Last update
Apr 6, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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