Local tumescent anaesthesia with ambulatory phlebectomy according to Muller principal

This research will relate to patients who will undergo ambulatory
flebectomieën. We mean that patients are classified according to the CEAP
classificatie4 and therefore can be treated surgically for varices using the
Muller technique.
The Muller technique means that, varicose veins through small incisions (about
1-2mm) removed with a flebotoom. At the height of the incisions by means of
local infiltration (tumescent anesthesia) with lidocaine for local anesthesia.
A flebotoom can best be described as a small spatula, with which the varicose
veins to be loosened so that the end with the aid of a Oeschhaakje, the varices
can be mounted and by the small skin incision are removed. By making use of the
millimeter large incisions to a few millimeters, it is not necessary to use
these to attach. This treatment will take about 60-90minuten take.

Tumescent (local) anesthesia involves anesthetic subcutaneously by the vascular
surgeon who will perform the procedure. This type of anesthesia is within a few
minutes (3-5) minutes incorporated and will average 90 minutes work. Tumescent
local anesthesia (LTA) is widely used in plastic surgery and dermatology among
other at flebectomie1. Local anesthesia in ambulatory phlebectomy procedures
regularly used, however this is often accompanied by many per-and postoperative
pain. This type of local anesthetic is also used for many years in plastic
surgery, including liposuction at. Here, very good results have been achieved,
inter alia, with less risk of bleeding and good pain control during and after
the procedures. However, the problem remains flebectomieën the per-and
postoperative pain that patients experience.
There are several ways to try to reduce this pain, it now appears that by
sodium bicarbonate in small concentrations to be added to the pain is
significantly reduced. A recent study has confirmed this effectiveness, by a
solution of 1% lidocaine diluted in 1.4% sodium bicarbonate varicose vein
surgery (Creton et al, 2011) 1. This study thus shows that the buffering of the
acid anesthetic improved pain reduction.
Creton et al1 shows a significant pain reduction, both perioperatively and
postoperatively by adding sodium bicarbonate 1.4% to the normal anesthetic.
Tumescent anesthesia with lidocaine 1% addition of dilute sodium bicarbonate
1.4% in varices surgery can provide a significant decrease in per-and
postoperative pijn1. The use of sodium bicarbonate as a mere excipient is 1.4%
LTA is much stronger, so that surgery is much easier, and there is no need for
intravenous sedatie1. The use of large volumes of dilute local anesthesia in
the subcutaneous tissues allows for anesthesia. Adrenaline reduces blood loss
and prolongs the duration of the anesthesie2

We want to demonstrate or exclude through this study that the administration of
a dilute solution anesthetic with sodium bicarbonate addition, using local
tumescent anesthesia technique, will lead to a significant decrease in per-and
postoperative pain in patients undergoing ambulatory phlebectomy will undergone
Muller.

The only difference with the current protocol in the hospital will consist of
the addition of sodium bicarbonate to the standard anesthetic. In short, the
buffering of the acid anesthetic, lidocaine, with the aid of sodium bicarbonate
the base, it will give less pain in patients who are ambulatory phlebectomy
will undergo according to the Muller technique. We will make use of lidocaine
1%, this is like the current protocol already provides for this type of
treatment.

The aim of this study is to demonstrate the benefits of reducing pain
associated with local infiltration anesthesia for ambulatory phlebectomy.
By means of a dilution of 1% Lidocaine anesthetic with epinephrine + 1.4%
sodium bicarbonate to solve

The study described above hypothesis and has led to the creation of the
following study. Preoperative informed consent will be obtained before patients
were randomized into 2 groups, the experimental group and the control group.
Assignment to group 1 or 2 will be independently produced and will be stored in
a separate file by the investigator.
Randomisation will take place on the basis of a randomization program
(http://www.graphpad.com/quickcalcs/randomize2.cfm). This randomization will be
performed before the study begins, so that the total population of 100 patients
were randomized to be immediately after inclusion and obtained informed
consent. Following participation patients will have a number assigned that will
lead to the eventual randomization. That is, experimental (A / B) or control (A
/ B) group. Assignment to group A or B will be independently produced and will
be stored in a separate file by the investigator.
Randomisation is done by the preoperative preparation of the solution by the
pharmacist. The pharmacist will advance a large amount of sodium bicarbonate
and sodium chloride prepared in vials of 16ml. These are then coded into A or
B. This encoding is allocated to the patients on the basis of the former
randomization. The perioperative nurse / surgeon vials of 16ml mixed with 4 ml
lidocaine 1%, as the research requires. In this way we ensure a double blind,
since both patient, surgeon and researcher is not aware of any fluid used
during the procedure. These fluids have a retention period of 24 months at room
temperature after fabrication.

In all patients, using the standardized analog VAS pain score to determine how
much pain they have, this will perioperatively and postoperatively on the day,
day 1, day 2, 1 and 2 weeks after the surgery to be recorded. It also will look
at content and restore functionality. These will be assessed with a
questionnaire.
The follow-up will be carried out by the researcher and the vascular surgeons
participating in the study. Patients will check out 2 weeks postoperatively,
after which they can indicate the degree of satisfaction of the VAS pain score.
It will also look at the potential intake of painkillers and whether this has
given satisfactory results. Also, time to return to work can be viewed and
restore functionality to look.
Patients will also be six weeks after surgery approached about satisfaction.
See diagram above for scores.

We want to demonstrate or exclude through this study that the administration of
a dilute anesthetic solution, using local tumescent anesthesia technique, will
lead to a significant decrease in per-and postoperative pain in patients
undergoing ambulatory phlebectomy according to Muller will undergo. The only
difference with the current therapy will consist of the addition of sodium
bicarbonate to the standard anesthetic. This standard, unlike the current
protocol in the hospital prescribed in the treatment of varicose veins. With
the idea that this basic solution the acid buffering lidocaine, with less pain
as a result. In short, the buffering of the acid anesthetic, lidocaine, with
the aid of sodium bicarbonate the base, it will give less pain in patients who
are ambulatory phlebectomy will undergo according to the Muller technique. The
aim of this study is to demonstrate the benefits of reducing pain associated
with local infiltration anesthesia for ambulatory phlebectomy. By means of a
dilution of 1% Lidocaine anesthetic with epinephrine + 1.4% sodium bicarbonate
to solve

The study described above hypothesis and has led to the creation of the
following study. Preoperative informed consent will be obtained before patients
were randomized into 2 groups, the experimental group and the control group.
Assignment to group 1 or 2 will be independently produced and will be stored in
a separate file by the investigator.
Randomisation is done by preoperative preparation of the solution by the
pharmacist. The pharmacist will advance a large amount of sodium bicarbonate
and sodium chloride prepared in vials of 16ml, accoording to protocol
describes. These are then coded into A or B. This encoding is allocated to the
patients on the basis of the former randomization. The perioperative nurse /
surgeon vials of 16ml mixed with 4 ml lidocaine 1%, as the research requires.
In this way we ensure a double blind, since both patient, surgeon and
researcher is not aware of any fluid used during the procedure. These fluids
have a retention period of 24 months at room temperature after fabrication.

In all patients, using the standardized analog VAS pain score to determine how
much pain they have, this will perioperatively and postoperatively on the day,
day 1, day 2, 1 and 2 weeks after the surgery to be recorded. It also will look
at content and restore functionality. These will be assessed with a
questionnaire.
The follow-up will be carried out by the researcher and the vascular surgeons
participating in the study. Patients will check out 2 weeks postoperatively,
after which they can indicate the degree of satisfaction of the VAS pain score.
It will also look at the potential intake of painkillers and whether this has
given satisfactory results. Also, time to return to work can be viewed and
restore functionality to look.
Patients will also be six weeks after surgery approached about satisfaction.
See diagram above for scores.

Experimental: Alkalinised anesthetic solution Drug: Lidocaïne chlorhydrate 1%
in Sodium Bicarbonate 1.4% 4 mL mepivacaine chlorhydrate 20 mg/mL with
epinephrine 5 mcg/mL diluted with 16 mL sodium bicarbonate 1.4% Other Names:
Active Comparator: Non alkalinised anesthetic solution Drug: Lidocaïne
chlorhydrate 1% with epinephrine in NS 0.9% 4 mL Lidocaïne chlorhydrate 20
mg/mL with epinephrine 5 mcg/mL diluted with 16 mL sodium chloride 0.9% Other
Names:

Nature and extent of the burden and risks associated with participation,
benefit and group relatedness (if applicable):
At a pre-set maximum dose on the basis of weight, there will be a
dose-dependent toxicity that can not be achieved. In addition, fewer patients
will have per- and postoperative pain. The low tax they undergo as a result of
completing the questionnaire and the high percentage of patients from previous
studies that this intervention would undergo again proves that the risks are
minimal, compared to the potentially significant benefits. Normally during
these surgery no more then 50-60milliliter anestheticum is used, this shows
that the maximum toxical limit is far from reached