NCT05345665

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
Last Updated

April 26, 2022

Status Verified

April 1, 2022

Enrollment Period

5 months

First QC Date

March 26, 2022

Last Update Submit

April 19, 2022

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Time

    Time to obtain a complete neuronal blockade of the hand

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

Study Arms (3)

Echography

OTHER

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

Other: EchographyOther: Echography and neurostimulationOther: Echography, neurostimulation and active mobilization

Neurostimulation

OTHER

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

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

Active mobilization

OTHER

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

Other: Echography, neurostimulation and active mobilization

Interventions

EchographyOTHER

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

Echography
Echography and neurostimulationOTHER

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

EchographyNeurostimulation
Echography, neurostimulation and active mobilizationOTHER

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

Active mobilizationEchographyNeurostimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • consecutive adult patients scheduled for an elective hand surgery

You may not qualify if:

  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Saint-Luc Bouge

Namur, 5004, Belgium

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Eric P Deflandre, MD, PhD

    Astes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department

Study Record Dates

First Submitted

March 26, 2022

First Posted

April 26, 2022

Study Start

March 1, 2021

Primary Completion

July 31, 2021

Study Completion

August 15, 2021

Last Updated

April 26, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)