NCT04305847

Brief Summary

Satisfaction assessment at 24 and 48 hours post operatively, after Axillary Brachial Plexus Block for Distal Arm Surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 20, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

December 21, 2020

Status Verified

December 1, 2020

Enrollment Period

5 months

First QC Date

February 20, 2020

Last Update Submit

December 18, 2020

Conditions

Satisfaction, Patient

Keywords

Anaesthesia, regionalaxillary brachial plexus block

Outcome Measures

Primary Outcomes (1)

  • Evan-LR score on day 2

    self administrated Evan-LR: "Evaluation du Vécu de l'Anesthésie LocoRégionale" 0-to-100 scale, with "100" indicating the best possible level of satisfaction and "0" the worst.

    at 48 hours postoperative

Secondary Outcomes (5)

  • Evan-LR score on day 1

    at 24 hours postoperative

  • Net Promotor score on day 2

    at 48 hours postoperative

  • Net Promotor score on day 1

    at 24 hours postoperative

  • Patient Satisfaction score on day 2

    at 48 hours postoperative

  • Patient Satisfaction score on day 1

    at 24 hours postoperative

Study Arms (1)

Qual'AXI group

patients for whom distal arm surgery was performed under Axillary Brachial Plexus Block

Other: perioperative satisfaction assessment

Interventions

perioperative satisfaction assessmentOTHER

Satisfaction assessment at 24 and 48 hours post operatively by self-administered survey questionnaire based on different scales: Evan-LR, Net Promotor Score, Satisfaction score.

Qual'AXI group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients for whom distal arm surgery was performed under Axillary Brachial Plexus Block in a single university hospital

You may qualify if:

  • patients for whom distal arm surgery was performed under Axillary Brachial Plexus Block

You may not qualify if:

  • Refusal, inability to consent
  • inability to fill self-administered survey questionnaire
  • pregnancy and breastfeeding
  • surgery \> 2 hours
  • second surgical site requiring anaesthesia or analgesia
  • chronic use of analgesia (including opioids) or illegal drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Besançon

Besançon, 25000, France

RECRUITING

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Francis Berthier, MD

CONTACT

0033381218980f1berthier@CHU-besancon.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2020

First Posted

March 12, 2020

Study Start

September 1, 2020

Primary Completion

January 31, 2021

Study Completion

January 31, 2021

Last Updated

December 21, 2020

Record last verified: 2020-12

Locations

FR(1)