Research with human participants

Overview of medical research in the Netherlands

A randomized controlled trial for Local Tumescent anesthesia with phlebectomy according to the Muller method.

No registrations found.

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Ethical review
Positive opinion
Status
Recruitment stopped
Health condition type
-
Study type
Interventional

ID

NL-OMON26677

Source

NTR

Brief title

LTAF

Health condition

Varicose veins
Varices
Tumescent anesthesia
Sodium bicarbonate

Sponsors and support

Primary sponsor :
None
Source(s) of monetary or material Support :
None

Intervention

Outcome measures

Primary outcome

Per- and postoperative pain

Secondary outcome

complications
time to full recovery/functionality
cost reduction.

Background summary

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.

Study objective

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.

Study design

Per-operative
2 hours postoperative
1 day postoperative
2 days postoperative
7 days postoperative
14 days postoperative

Intervention

Intevention: lidocaïne chloorhydrate 1% with epinephrine in natriumbicarbonate1.4%
Control: standard LTA (lidocaïne chloorhydrate 1% with epinephrine in normal saline 0.9%

Public
Atrium MC Parkstad<br>
Afd. Algemene Heelkunde<br>
Henri Dunantstraat 5
A.G. Krasznai
Heerlen 6419 PC
The Netherlands
+31 (0)45 5766666
Scientific
Atrium MC Parkstad<br>
Afd. Algemene Heelkunde<br>
Henri Dunantstraat 5
A.G. Krasznai
Heerlen 6419 PC
The Netherlands
+31 (0)45 5766666

Inclusion criteria

Older than 18 years
Indication for Muller Phlebectomy according to the CEAP classification

Exclusion criteria

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

Design

Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Double blinded (masking used)
Control :
Active

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
110
Type :
Actual

Positive opinion
Date :
Application type :
First submission

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
NTR-new NL4337
NTR-old NTR4534
Other METC : 12-T-77

Summary results

None