Trigger Finger DisorderWALANTNCT03663608
Wide Awake Local Anesthesia No Tourniquet
An observational study of Trigger Finger Disorder, run by Rennes University Hospital at 2 sites in France.
Trial summary
The main objective is to assess patient's satisfaction regarding pure local anaesthesia and without use of a tourniquet (WALANT Technique) for trigger finger release surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigger Finger Disorder
- What is being tested?
- WALANT Technique
- Type of treatment
- Surgery or procedure
- How many people
- 57 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Nov 2017to 12 Nov 2018
- 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
- Adult, Older adult
Study population: Patients with Isolated Trigger finger, diagnosis confirmed by sonography and indication of surgical release
Who may be able to join
- Patients of age
- Isolated Trigger finger, diagnosis confirmed by sonography and with indication of surgical release
- Patients protected by health insurance
- Patients who have received proper information on the current research proctol, and did not refuse to enter the study
Who cannot join
- Hand vascular disorders ( History of finger replantation surgery, clinical signs of poor hand vascularization
- Hypersensitivy to Xylocain or Adrenalin or one of it's components
- Other surgical act planned to be performed during the same anaesthesia
- Pregnant or Breastfeeding women
- Patients of age and under the protection of a conservator, patients deprived of liberty
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Privé de Plérin
Plérin, 22190
CHU de Rennes
Rennes, 35033
About this study
The main objective is to assess patient's satisfaction regarding pure local anaesthesia and without use of a tourniquet (WALANT Technique) for trigger finger release surgery.
- Conditions
- Trigger Finger Disorder
- Being tested
- WALANT Technique
- Medical subject headings
- Trigger Finger Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WALANT TechniqueProcedure or surgery
pure local anaesthesia and without use of a tourniquet (WALANT Technique) for trigger finger release surger
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Patient's agreement to use WALANT for possible surgeries to come and Patient's agreement to refer WALANT to his close relatives if they were to undergo surgery
Measured: one day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start20 Nov 2017
- Primary completion12 Nov 2018
- Study completion12 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger Finger DisorderStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663608
- Sponsor's protocol ID
- 35RC17-3065_WALANT
- Acronym
- WALANT
- Status last verified
- Apr 2022
- First submitted
- 6 Sep 2018
- Last updated
- 5 Apr 2022
- 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 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wide Awake Local Anesthesia No Tourniquet
- ClinicalTrials.gov ID
- NCT03663608
- Acronym / sponsor ID
- WALANT / 35RC17-3065_WALANT
- Conditions
- Trigger Finger Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 12 Nov 2018 (actual)
- Study completion
- 12 Nov 2018 (actual)
- First posted
- 10 Sep 2018 (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.
The main objective is to assess patient's satisfaction regarding pure local anaesthesia and without use of a tourniquet (WALANT Technique) for trigger finger release surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with Isolated Trigger finger, diagnosis confirmed by sonography and indication of surgical release
Key inclusion criteria (4 listed)
- Patients of age
- Isolated Trigger finger, diagnosis confirmed by sonography and with indication of surgical release
- Patients protected by health insurance
- Patients who have received proper information on the current research proctol, and did not refuse to enter the study
Key exclusion criteria (5 listed)
- Hand vascular disorders ( History of finger replantation surgery, clinical signs of poor hand vascularization
- Hypersensitivy to Xylocain or Adrenalin or one of it's components
- Other surgical act planned to be performed during the same anaesthesia
- Pregnant or Breastfeeding women
- Patients of age and under the protection of a conservator, patients deprived of liberty
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 |
|---|---|---|
| WALANT Techniquepure local anaesthesia and without use of a tourniquet (WALANT Technique) for trigger finger release surger | Procedure or surgery | – |
Primary outcome
Patient satisfaction
Time frame: one day after surgery
Patient's agreement to use WALANT for possible surgeries to come and Patient's agreement to refer WALANT to his close relatives if they were to undergo surgery
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 5 Apr 2022.
Related trials for Trigger Finger Disorder
Recruiting
A Clinical Study to Compare Functional Outcomes After Surgery Using a Transverse or Longitudinal Surgical Incision in the Skin.
Functional Disturbance as Result
Recruiting
Low-Level Laser Therapy in the Treatment of Trigger Finger
Trigger Finger, Stenosing Tenosynovitis
Not yet recruiting
Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test
Non-traumatic Musculoskeletal Conditions, Carpal Tunnel Syndrome (CTS)
Enrolling by invitation
A Comparison of Metacarpophalangeal Joint Blocking Splint With Relative Motion Extension Splint for Trigger Finger
Trigger Finger
RecruitingPhase 4
Ketorolac in Upper Extremity Tendinopathy and Arthropathy
Osteoarthritis, Tendinopathy
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trigger Finger Disorder, run by Rennes University Hospital at 2 sites 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 4 inclusion and 5 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 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Patient satisfaction (time frame: one day after surgery). 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 5 Apr 2022.