Satisfaction, PatientQual'AXINCT04305847
Satisfaction Assessment After Axillary Block
An observational study of Satisfaction, Patient, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Satisfaction assessment at 24 and 48 hours post operatively, after Axillary Brachial Plexus Block for Distal Arm Surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Satisfaction, Patient
- What is being tested?
- perioperative satisfaction assessment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2020to 31 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients for whom distal arm surgery was performed under Axillary Brachial Plexus Block in a single university hospital
Who may be able to join
- patients for whom distal arm surgery was performed under Axillary Brachial Plexus Block
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Besançon
Besançon, 25000
Francis BERTHIER, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Satisfaction, Patient
- Being tested
- perioperative satisfaction assessment
- Keywords
- Anaesthesia, regional, axillary brachial plexus block
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Qual'AXI group | patients for whom distal arm surgery was performed under Axillary Brachial Plexus Block Receives: Other: perioperative satisfaction assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 48 hours postoperative
Secondary outcomes (5)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: at 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start1 Sep 2020
- Primary completion31 Jan 2021 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Satisfaction, PatientStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305847
- Sponsor's protocol ID
- P/2020/480
- Acronym
- Qual'AXI
- Status last verified
- Dec 2020
- First submitted
- 20 Feb 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual Participant Data (IPD) Sharing Statement depending on the institutional modality under development
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satisfaction Assessment After Axillary Brachial Plexus Block for Distal Arm Surgery
- ClinicalTrials.gov ID
- NCT04305847
- Acronym / sponsor ID
- Qual'AXI / P/2020/480
- Conditions
- Satisfaction, Patient
- Keywords
- Anaesthesia, regional, axillary brachial plexus block
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 12 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Satisfaction assessment at 24 and 48 hours post operatively, after Axillary Brachial Plexus Block for Distal Arm Surgery.
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
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Qual'AXI group | – | Other: perioperative satisfaction assessmentpatients for whom distal arm surgery was performed under Axillary Brachial Plexus Block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients for whom distal arm surgery was performed under Axillary Brachial Plexus Block in a single university hospital
Key inclusion criteria (1 listed)
- patients for whom distal arm surgery was performed under Axillary Brachial Plexus Block
Key exclusion criteria (6 listed)
- Refusal, inability to consent
- inability to fill self-administered survey questionnaire
- pregnancy and breastfeeding
- surgery > 2 hours
- second surgical site requiring anaesthesia or analgesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| perioperative satisfaction assessmentSatisfaction assessment at 24 and 48 hours post operatively by self-administered survey questionnaire based on different scales: Evan-LR, Net Promotor Score, Satisfaction score. | Other | Qual'AXI group |
Primary outcome
Evan-LR score on day 2
Time frame: 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.
5 secondary outcomes
Evan-LR score on day 1
Time frame: at 24 hours postoperative
Net Promotor score on day 2
Time frame: at 48 hours postoperative
Net Promotor score on day 1
Time frame: at 24 hours postoperative
Patient Satisfaction score on day 2
Time frame: at 48 hours postoperative
Patient Satisfaction score on day 1
Time frame: at 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Individual participant dataSharing planned: Undecided. Individual Participant Data (IPD) Sharing Statement depending on the institutional modality under development
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Satisfaction, Patient, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francis Berthier, MD (0033381218980, f1berthier@CHU-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evan-LR score on day 2 (time frame: at 48 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020.