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Wide Awake Local Anesthesia No Tourniquet (WALANT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663608
Recruitment Status : Unknown
Verified September 2018 by Rennes University Hospital.
Recruitment status was:  Recruiting
First Posted : September 10, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief 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.

Condition or disease Intervention/treatment
Trigger Finger Disorder Procedure: WALANT Technique

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Wide Awake Local Anesthesia No Tourniquet
Actual Study Start Date : November 20, 2017
Estimated Primary Completion Date : November 20, 2018
Estimated Study Completion Date : November 23, 2018

Intervention Details:
  • Procedure: WALANT Technique
    pure local anaesthesia and without use of a tourniquet (WALANT Technique) for trigger finger release surger


Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663608


Contacts
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Contact: Kristell COAT 2 99 28 91 91 kristell.coat@chu-rennes.fr
Contact: Direction de la Recherche 2 99 28 25 55 ext +33 drc@chu-rennes.fr

Locations
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France
Centre Hospitalier Privé de Plérin Recruiting
Plérin, France, 22190
Contact: Benoit Renaud, MD         
Principal Investigator: Benoit Renaud, MD         
CHU de Rennes Recruiting
Rennes, France, 35033
Contact: Warren KIM, MD         
Principal Investigator: Warren KIM, MD         
Sponsors and Collaborators
Rennes University Hospital
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03663608    
Other Study ID Numbers: 35RC17-3065_WALANT
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Trigger Finger Disorder
Tendon Entrapment
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases