Wide Awake Local Anesthesia No Tourniquet | NCT03663608

Studies
Wide Awake Local Anesthesia No Tourniquet

NCT03663608

Sponsor

Rennes University Hospital

Status

Completed

Last Update Posted

Apr 5, 2022Actual

Enrollment

57Actual

Phase

Not provided

Conditions

Trigger Finger Disorder

Interventions

WALANT Technique

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 20, 2017Actual

Primary Completion Date

Nov 12, 2018Actual

Completion Date

Nov 12, 2018Actual

First Submitted Date

Sep 6, 2018

First Submission Date that Met QC Criteria

Sep 6, 2018

First Posted Date

Sep 10, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2022

Last Update Posted Date

Apr 5, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

57Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
WALANT Technique	Procedure	pure local anaesthesia and without use of a tourniquet (WALANT Technique) for trigger finger release surger

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	one day after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with Isolated Trigger finger, diagnosis confirmed by sonography and indication of surgical release

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Privé de Plérin		Plérin		22190	France
CHU de Rennes

Condition Browse Module

MeSH Terms

ID	Term
D052582	Trigger Finger Disorder

Ancestor Terms

ID	Term
D053682	Tendon Entrapment
D052256	Tendinopathy
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided