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A comparison of two anesthetic techniques for VNUS closureFAST procedure: local or locoregional

Conditions
varicose veins
varicosis
10003184
10057165
Registration Number
NL-OMON33088
Lead Sponsor
Diakonessenhuis Utrecht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
110
Inclusion Criteria

- All single sided VNUS closureFAST procedures, without convolutectomy
- informed consent
- CEAP-classification 2 and 3
- duplex ultrasound confirmed varicosis
- age * 18 years old
- good comprehension of the dutch language

Exclusion Criteria

- VNUS closureFAST procedure both sides
- pre-existent neurological damage or - disabilities of the leg
- contra-indications for VNUS closureFAST procedure: recidive varicosis, lumen of the vein to wide, very twisting vein, to many convolutes.
- contra-indication for local or locoregional anesthesia: over-sensitiveness for lidocain and/or mepivacain
- preference for general anesthesia
- legally incapable

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Primary outcome: pain during the VNUS closureFAST procedure, measured as a<br /><br>numerric score of the mean pain during the procedure.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secundary outcomes:<br /><br>* Patiënt satisfaction<br /><br>* Postoperative pain<br /><br>* (prolonged) block at the time of discharge after locoregional anesthesia<br /><br>* Duration of the procedure excluding anesthesia and including anesthesia<br /><br>* Duration of hospital admission, possible extended admission time<br /><br>* Satisfaction surgeon<br /><br>* Complications:<br /><br>* Toxicity (systemic)<br /><br>* Nerve damage (by locoregional block, local anesthesia/compression, surgery )<br /><br>* Burns<br /><br>* Postoperative bleeding<br /><br>* Failed procedure, surgical<br /><br>* Failed block</p><br>
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