Upper Gastrointestinal Cancer Clinical Trial
Acute post-operative pain causes not only discomfort for the patient, but delays recovery by
increasing the morbidity of the circulatory system, respiratory system, and immune system,
so pain control is one of the important objectives in peri-operative patient management.
Patient controlled analgesia (PCA) is a piece of equipment for which the patient can
personally control the administration of an analgesic. It is generally used in postoperative
pain management because it is a method which can heighten patient satisfaction by reducing
complications and obtaining the appropriate level of pain relief. Usually, it is designed to
administer an analgesic at a steady speed, and the patient can administer additional
medication by pressing a button when the pain is severe. Here, to prevent complications from
excessive administration of an analgesic, repeated administration is not allowed within a
certain time interval. The PCA equipment can be categorized as electronic and physical
according to the force which operates the drug injection pump. Electronic equipment uses
electrical energy to apply vermicular movement to the fluid tube to administer the
analgesic. Physical equipment is disposable equipment designed to fill an elastomer
reservoir bag expanding the material, and its elasticity returns to the original length used
to administer the analgesic. The physical equipment is easy to carry and movement is
comfortable because there is no need for additional electronic equipment or devices. There
is also no need for special training to operate the equipment, and the action mechanism is
simple so there is less opportunity for malfunction. The disposable physical equipment
accounts for approximately 70% of the domestic market share and it is preferred over the
electronic equipment. On the other hand, contrary to the electronic equipment, the physical
PCA equipment has the disadvantage of not providing information regarding the history of the
equipment's use. The early physical PCA equipment was very simple and only had the function
of continually administering medication at a set speed. Hence, it was not sufficient to
function as 'patient controlled' pain control equipment. Then, the function of an additional
administration button was added so that the patient can personally decide whether to
administer an additional amount of analgesic. At the same time, the physical PCA equipment
has improved to prevent excessive administration by setting a lock-out time as a safety
measure. The following development was Accufuser Selectuss®, where a function was added to
select the administration speed from three options. In this way, the physical PCA equipment
has continued to evolve in the direction of enhancing safety, convenience, and clinical
effectiveness. The advantage of pain control using PCA equipment is that the patient can
personally control additional the administration of an analgesic by pressing a button. In
the case of existing or imported products, it is designed to administer a bolus by pressing
the button, and the pressure presses the PVC bag filled with medication under the button to
administer the bolus. Compared to the intravenous route, using an epidural as a PCA
administration route has superior analgesic effect, so it can reduce the amount of opioid
analgesic administered. On the other hand, the disadvantage is that it has to pass through a
narrow and long epidural catheter to deliver the medication to the epidural space which has
a relatively higher resistance. Woo Young Medical experimented with their own product
Accufuser plus® (Woo Young Medical, Korea), and the results showed that the time taken to
empty the bolus bag was approximately 40-80 seconds depending on the dosage. The pressure
when a person presses the bolus button on the PCA equipment was repeatedly measured to
obtain a mean value, and this pressure was constantly maintained by a machine to measure the
time taken to empty the bolus bag. Clinically, it is not easy to continually press the
button for 40-80 seconds, so it is difficult to exclude the possibility that the bolus was
not administered properly. In addition, when excessive pressure is applied, there is the
possibility that the bolus bag may burst. The domestically developed products and Accufuser
Omnibus® (Woo Young Medical, Korea) was developed for the purpose of supplementing bolus
failure which can occur when using epidural PCA. Within the bolus module, a second
elastomeric balloon is installed behind the first bolus bag so the patient does not have to
press the bolus button for a long time.
Therefore, this research focused on the effectiveness and safety of the domestic product
Accufuser Omnibus® (Woo Young Medical, Korea) regarding whether the bolus is sufficiently
delivered when it is administered through the epidural route, and compared the results
through a comparative clinical trial with imported physical PCA equipment (Infusor SV®,
Baxter, USA).
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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