Satisfaction Assessment After Axillary Block (Qual'AXI)

Satisfaction Assessment After Axillary Brachial Plexus Block for Distal Arm Surgery

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

Study Overview

• Status: Unknown
• Conditions: Satisfaction, Patient
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Francis Berthier, MD; Phone Number: 0033381218980; Email: f1berthier@CHU-besancon.fr

Study Locations

• France
  • Besancon, France, 25000
    • Recruiting
    • CHU de Besancon
    • Contact: Francis BERTHIER, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evan-LR score on day 1	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 24 hours postoperative
Net Promotor score on day 2	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	at 48 hours postoperative
Net Promotor score on day 1	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	at 24 hours postoperative
Patient Satisfaction score on day 2	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	at 48 hours postoperative
Patient Satisfaction score on day 1	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	at 24 hours postoperative

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2020
• Primary Completion (ANTICIPATED): January 31, 2021
• Study Completion (ANTICIPATED): January 31, 2021

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (ACTUAL): March 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 18, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Anaesthesia, regional; axillary brachial plexus block
• Other Study ID Numbers: P/2020/480

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual Participant Data (IPD) Sharing Statement depending on the institutional modality under development

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No