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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33088

Enrollment

110

Registered

2009-09-04

Start date

2009-03-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

varicose veins varicosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Primary outcome: pain during the VNUS closureFAST procedure, measured as a numerric score of the mean pain during the procedure.	—

Secondary

Measure	Time frame
Secundary outcomes: * Patiënt satisfaction * Postoperative pain * (prolonged) block at the time of discharge after locoregional anesthesia * Duration of the procedure excluding anesthesia and including anesthesia * Duration of hospital admission, possible extended admission time * Satisfaction surgeon * Complications: * Toxicity (systemic) * Nerve damage (by locoregional block, local anesthesia/compression, surgery ) * Burns * Postoperative bleeding * Failed procedure, surgical * Failed block	—

Measure

Time frame

Secundary outcomes: * Patiënt satisfaction * Postoperative pain * (prolonged) block at the time of discharge after locoregional anesthesia * Duration of the procedure excluding anesthesia and including anesthesia * Duration of hospital admission, possible extended admission time * Satisfaction surgeon * Complications: * Toxicity (systemic) * Nerve damage (by locoregional block, local anesthesia/compression, surgery ) * Burns * Postoperative bleeding * Failed procedure, surgical * Failed block

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Countries

Netherlands

Outcome results