AnesthesiologyWALAXNCT04855149
Satisfaction Survey After Distal Surgery Performed Under Local Infiltration (Walant) or Under Axillary Block
An observational study of Anesthesiology and Satisfaction, Patient, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
In the 1970s-1980s, Dr. Donald Lalonde (surgeon, Canada) developed an anesthetic technique for hand surgery called WALANT (Wide Awake Local Anesthesia No Tourniquet). This technique is based on the joint administration of a local anesthetic (lidocaine) and epinephrine (adrenaline), which limits bleeding and makes it… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesiology, Satisfaction, Patient, Surgery
- What is being tested?
- Patient satisfaction
- How many people
- 202 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2019to 1 Dec 2020
- 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: The patients included in the study are patients at least 18 years old, hospitalized for scheduled surgery, who have accepted the principle of the study, are able to complete the EVAN-G questionnaire and are able to walk alone.
Who may be able to join
- Age > 18 yars
- scheduled surgery of the hand, wrist or elbow under local or loco-regional anesthesia
- Consent to participate
Who cannot join
- contraindication to loco-regional or local anesthesia
- allergy to the products administered (lidocaine, epinephrine)
- pregnant woman
- comprehension disorder (confusion, cognitive disorder...) or linguistic disorder that does not allow answering the follow-up questionnaires
- refusal to participate or to follow up
- surgery in emergency or under general anesthesia
- Translated with www.DeepL.com/Translator (free version)
Trial locations and contacts
1 site in 1 country.
About this study
In the 1970s-1980s, Dr. Donald Lalonde (surgeon, Canada) developed an anesthetic technique for hand surgery called WALANT (Wide Awake Local Anesthesia No Tourniquet). This technique is based on the joint administration of a local anesthetic (lidocaine) and epinephrine (adrenaline), which limits bleeding and makes it possible to dispense with a tourniquet. In addition, and contrary to truncal anesthesia, this combination of drugs infiltrated opposite the surgical site preserves the mobility of the limb. However, this technique is not without risk and some adverses events have been reported: intoxication by local anesthetics due to overdose and digital necrosis with the use of procaine or cocaine.
Currently in France, truncal anesthesia with a pneumatic tourniquet on the arm is often preferred for hand surgery (axillary block or BAx). In this case, the pneumatic tourniquet is used to minimize intraoperative blood loss and improve the visibility of the operating field. However, it can be a source of discomfort, pain, or transient neurological deficit.
Read more
To date, few studies comparing WALANT and BAx are available and none have evaluated the perioperative experience of patients and the incidence of paresthesias in the short and long term.
In order to measure the perioperative satisfaction of patients undergoing hand surgery with BAx or WALANT, we conduct a prospective observational non-randomized study evaluating the EVAN-LR satisfaction score at D0. The secondary objectives of the study are to evaluate postoperative adverse events (digital necrosis, paresthesias, local anesthetic intoxications, infection of the operated limb), consumption of postoperative analgesic treatments in both groups.
- Conditions
- Anesthesiology, Satisfaction, Patient, Surgery
- Being tested
- Patient satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient satisfactionOther
Patient satisfaction evaluated with EVAN LR questionnaire
| Study group | Role | What they receive |
|---|---|---|
| WALANT | anesthesia performed with WALANT technique Receives: Other: Patient satisfaction | |
| BAx | anesthesia performed with axillary block under ultrasound control Receives: Other: Patient satisfaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction of day case surgery
Satisfaction of day case surgery measured with EVAN LR score (EVAN LR : Evaluation du Vécu de l'Anesthésie LocoRégionale; the EVAN-LR comprises 19 items, structured in a global index and five dimensions: Attention, Information, Discomfort, Waiting, and Pain; , All dimensions are scored on a scale from 0 to 100, with 100 indicating the best possible level of satisfaction and 0 the worst)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start1 Oct 2019
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiologyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Cuvillon, Principal investigator, CHU NIMES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855149
- Sponsor's protocol ID
- Local/2020/PC-01
- Acronym
- WALAX
- Status last verified
- Apr 2021
- First submitted
- 19 Apr 2021
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satisfaction Survey After Distal Surgery Performed Under Local Infiltration (Walant) or Under Axillary Block
- ClinicalTrials.gov ID
- NCT04855149
- Acronym / sponsor ID
- WALAX / Local/2020/PC-01
- Conditions
- Anesthesiology, Satisfaction, Patient, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 22 Apr 2021 (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.
In the 1970s-1980s, Dr. Donald Lalonde (surgeon, Canada) developed an anesthetic technique for hand surgery called WALANT (Wide Awake Local Anesthesia No Tourniquet). This technique is based on the joint administration of a local anesthetic (lidocaine) and epinephrine (adrenaline), which limits bleeding and makes it possible to dispense with a tourniquet. In addition, and contrary to truncal anesthesia, this combination of drugs infiltrated opposite the surgical site preserves the mobility of the limb. However, this technique is not without risk and some adverses events have been reported: intoxication by local anesthetics due to overdose and digital necrosis with the use of procaine or cocaine.
Currently in France, truncal anesthesia with a pneumatic tourniquet on the arm is often preferred for hand surgery (axillary block or BAx). In this case, the pneumatic tourniquet is used to minimize intraoperative blood loss and improve the visibility of the operating field. However, it can be a source of discomfort, pain, or transient neurological deficit.
To date, few studies comparing WALANT and BAx are available and none have evaluated the perioperative experience of patients and the incidence of paresthesias in the short and long term.
In order to measure the perioperative satisfaction of patients undergoing hand surgery with BAx or WALANT, we conduct a prospective observational non-randomized study evaluating the EVAN-LR satisfaction score at D0. The secondary objectives of the study are to evaluate postoperative adverse events (digital necrosis, paresthesias, local anesthetic intoxications, infection of the operated limb), consumption of postoperative analgesic treatments in both groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WALANT | – | Other: Patient satisfactionanesthesia performed with WALANT technique |
| BAx | – | Other: Patient satisfactionanesthesia performed with axillary block under ultrasound control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients included in the study are patients at least 18 years old, hospitalized for scheduled surgery, who have accepted the principle of the study, are able to complete the EVAN-G questionnaire and are able to walk alone.
Key inclusion criteria (3 listed)
- Age > 18 yars
- scheduled surgery of the hand, wrist or elbow under local or loco-regional anesthesia
- Consent to participate
Key exclusion criteria (7 listed)
- contraindication to loco-regional or local anesthesia
- allergy to the products administered (lidocaine, epinephrine)
- pregnant woman
- comprehension disorder (confusion, cognitive disorder...) or linguistic disorder that does not allow answering the follow-up questionnaires
- refusal to participate or to follow up
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 |
|---|---|---|
| Patient satisfactionPatient satisfaction evaluated with EVAN LR questionnaire | Other | BAx, WALANT |
Primary outcome
Satisfaction of day case surgery
Time frame: Day 0
Satisfaction of day case surgery measured with EVAN LR score (EVAN LR : Evaluation du Vécu de l'Anesthésie LocoRégionale; the EVAN-LR comprises 19 items, structured in a global index and five dimensions: Attention, Information, Discomfort, Waiting, and Pain; , All dimensions are scored on a scale from 0 to 100, with 100 indicating the best possible level of satisfaction and 0 the worst)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
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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.
Philippe Cuvillon principal investigator
CHU NIMES
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 Anesthesiology and Satisfaction, Patient, run by Centre Hospitalier Universitaire de Nīmes 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 20 Aug 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction of day case surgery (time frame: Day 0). 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 20 Aug 2021.