The aim of this randomised controlled trial is to compare if adding sodium bicarbonate 1.4% to lidocain chloorhydrate 1% and epinifrine 0.9% results in significant less per-and postoperative pain in comparison with the routine LTA epinifrine 0.9%…
ID
Bron
Verkorte titel
Aandoening
Varicose veins
Varices
Tumescent anesthesia
Sodium bicarbonate
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Per- and postoperative pain
Achtergrond van het onderzoek
The aim of this randomised controlled trial is to compare if adding sodium bicarbonate 1.4% to lidocain chloorhydrate 1% and epinifrine 0.9% results in significant less per-and postoperative pain in comparison with the routine LTA epinifrine 0.9% and lidocain chloorhydrate 1% in ambulant phlebectomy according to the Muller Method. Secondary outcomes are complications, time to full recovery/functionality and cost reduction.
Doel van het onderzoek
The aim of this randomised controlled trial is to compare if adding sodium bicarbonate 1.4% to lidocain chloorhydrate 1% and epinifrine 0.9% results in significant less per-and postoperative pain in comparison with the routine LTA epinifrine 0.9% and lidocain chloorhydrate 1% in ambulant phlebectomy according to the Muller Method.
Onderzoeksopzet
Per-operative
2 hours postoperative
1 day postoperative
2 days postoperative
7 days postoperative
14 days postoperative
Onderzoeksproduct en/of interventie
Intevention: lidocaïne chloorhydrate 1% with epinephrine in natriumbicarbonate1.4%
Control: standard LTA (lidocaïne chloorhydrate 1% with epinephrine in normal saline 0.9%
Publiek
Afd. Algemene Heelkunde<br>
Henri Dunantstraat 5
A.G. Krasznai
Heerlen 6419 PC
The Netherlands
+31 (0)45 5766666
Wetenschappelijk
Afd. Algemene Heelkunde<br>
Henri Dunantstraat 5
A.G. Krasznai
Heerlen 6419 PC
The Netherlands
+31 (0)45 5766666
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Older than 18 years
Indication for Muller Phlebectomy according to the CEAP classification
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
allergy to anesthesia
acute diseases
chronic kidney- or liver failure
analgetics treatment
treatment with monoamine oxidase inhibitors or tricyclic antidepressants
psychiatric illness according to the DSM-IV classification criteria
alcohol abuses
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4337 |
| NTR-old | NTR4534 |
| Ander register | METC : 12-T-77 |