Qual'AXI: Satisfaction Assessment After Axillary Block

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Recruiting

CT.gov ID

NCT04305847

Collaborator

(none)

200

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Satisfaction, Patient	Other: perioperative satisfaction assessment

Detailed Description

Inclusion after distal Arm Surgery performed under Axillary Brachial Plexus Block.

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

Satisfaction Assessment After Axillary Brachial Plexus Block for Distal Arm Surgery

Actual Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Jan 31, 2021

Anticipated Study Completion Date :

Jan 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Qual'AXI group patients for whom distal arm surgery was performed under Axillary Brachial Plexus Block	Other: perioperative satisfaction assessment 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.

Arm

Intervention/Treatment

Qual'AXI group

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

Other: perioperative satisfaction assessment

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.

Outcome Measures

Primary Outcome Measures

Evan-LR score on day 2 [at 48 hours postoperative]
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.

Secondary Outcome Measures

Evan-LR score on day 1 [at 24 hours postoperative]
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.
Net Promotor score on day 2 [at 48 hours postoperative]
self administrated Net Promotor score: willingness to advise a relative to undergo the same operation on a scale from 0 to 10. Based on the score, patients are divided into promoters (9 or 10), passives (7 or 8), and detractors (under 6). The NPS is determined as follows: NPS = % promoters - % detractors
Net Promotor score on day 1 [at 24 hours postoperative]
self administrated Net Promotor score: willingness to advise a relative to undergo the same operation on a scale from 0 to 10. Based on the score, patients are divided into promoters (9 or 10), passives (7 or 8), and detractors (under 6). The NPS is determined as follows: NPS = % promoters - % detractors
Patient Satisfaction score on day 2 [at 48 hours postoperative]
self administrated Satisfaction score: scale from 0 to 10. A score of "0" meant extremely dissatisfied and that a score of "10" meant extremely satisfied
Patient Satisfaction score on day 1 [at 24 hours postoperative]
self administrated Satisfaction score: scale from 0 to 10. A score of "0" meant extremely dissatisfied and that a score of "10" meant extremely satisfied

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Besançon	Besancon		France	25000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Besancon

ClinicalTrials.gov Identifier:

NCT04305847

Other Study ID Numbers:

P/2020/480

First Posted:

Mar 12, 2020

Last Update Posted:

Dec 21, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire de Besancon

Anaesthesia, regional

axillary brachial plexus block

Study Results

No Results Posted as of Dec 21, 2020