This study aims to show by which technique the patient feels the least pain. It is also designed to show which advantages and disadvantages are linked to the abovementioned forms of anesthesia and if there are differences in postoperative pain…
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
- Venous varices
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: pain during the VNUS closureFAST procedure, measured as a
numerric score of the mean pain during the procedure.
Secondary outcome
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
Background summary
Varicosis is a common ailment. The VNUS closureFAST procedure (FDA approved
1999) is an alternative to traditional stripping of the insufficient VSM. This
endovascular radiofrequent ablation is accepted as a good alternative to
conventional surgery. The procedure can be carried out under local or
locoregional anesthesia. To date, no research has been done into which
anesthesia technique is most suitable.
Study objective
This study aims to show by which technique the patient feels the least pain. It
is also designed to show which advantages and disadvantages are linked to the
abovementioned forms of anesthesia and if there are differences in
postoperative pain experiences. From this a conclusion can be made as to which
form of anesthesia is preferential for the VNUS closureFAST procedure.
Study design
Randomized Controled Trial. After the patients have given informed consent and
are included in the trial, they will be randomized in two groups. One group
will receive local anesthesie, the other group locoregional anesthesia.
Study burden and risks
The patient will not be exposed to any extra risks than during the current
standard treatment. At this moment both anesthesia techniques are used. The
patient must be prepared to answer some questions regarding pain and
satisfaction.
postbus 80250
3508 TG utrecht
Nederland
postbus 80250
3508 TG utrecht
Nederland
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL26394.100.09 |