- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03663608
Wide Awake Local Anesthesia No Tourniquet (WALANT)
April 4, 2022 updated by: Rennes University Hospital
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
57
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Plérin, France, 22190
- Centre Hospitalier Privé de Plérin
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Rennes, France, 35033
- CHU de Rennes
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with Isolated Trigger finger, diagnosis confirmed by sonography and indication of surgical release
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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one day after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 20, 2017
Primary Completion (Actual)
November 12, 2018
Study Completion (Actual)
November 12, 2018
Study Registration Dates
First Submitted
September 6, 2018
First Submitted That Met QC Criteria
September 6, 2018
First Posted (Actual)
September 10, 2018
Study Record Updates
Last Update Posted (Actual)
April 5, 2022
Last Update Submitted That Met QC Criteria
April 4, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35RC17-3065_WALANT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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