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CompletedNCT05345665Updated Apr 26, 2022

Comparison of Three Methods of Anesthesia to Achieve a Nerve Block Anesthesia.

An interventional study of Echography and Echography and neurostimulation in Anesthesia, sponsored by Astes. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-26.

Sponsored by Astes · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
216
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Evaluation of three methods for the realization of a neuronal blockade.

Read the detailed description

Evaluation of three methods during the realization of a neuronal blockade. The three stimulations were: 1) echography, 2) echography and neurostimulation, and 3) echography, neurostimulation, and active mobilization by the patient.

02

Conditions studied

  • Anesthesia
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 216 consecutive adult patients scheduled for an elective hand surgery

Exclusion criteria

Exclusion Criteria:

  • Patient refusal
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
216 participants (actual)

Study arms

  • Other
    Echography

    For the neuronal blockade of the patient, anesthesiologists used an echography.

    Other: Echography · Other: Echography and neurostimulation · Other: Echography, neurostimulation and active mobilization

  • Other
    Neurostimulation

    For the neuronal blockade of the patient, anesthesiologists used neurostimulation.

    Other: Echography and neurostimulation · Other: Echography, neurostimulation and active mobilization

  • Other
    Active mobilization

    For the neuronal blockade of the patient, anesthesiologists used active mobilization.

    Other: Echography, neurostimulation and active mobilization

Interventions

  • OtherEchography

    Neuronal blockade anesthesia for elective surgery of the hand was performed with an only echography.

  • OtherEchography and neurostimulation

    Neuronal blockade anesthesia for elective surgery of the hand was performed with both echography and neurostimulation.

  • OtherEchography, neurostimulation and active mobilization

    Neuronal blockade anesthesia for elective surgery of the hand was performed with echography, neurostimulation, and active mobilization.

05

What researchers measure

Primary outcomes

  1. Time

    Time to obtain a complete neuronal blockade of the hand

    Time frame: Measurements was performed during 20 minutes after the completion of the neuronal blockade.

06

Study locations

1 site
  • Clinique Saint-Luc Bouge
    Namur, 5004, Belgium
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05345665
Lead sponsor
Astes
Responsible party
Eric DEFLANDRE, MD, PhD, FCCP, FAHA (Head of Department, Astes) — Principal investigator
First posted
Apr 26, 2022
Start date
Mar 1, 2021
Primary completion
Jul 31, 2021
Completion
Aug 15, 2021
Last update
Apr 26, 2022

Study contacts

Eric P Deflandre, MD, PhD
principal investigator · Astes

Oversight

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

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