The Efficacy and Safety of Accufuser Omnibus® (Elastomeric Infusion Pump); Comparative Clinical Trial
Condition: Upper Gastrointestinal Cancer
MeSH terms: Gastrointestinal Neoplasms
Study type: Interventional

Summary: 
      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).
    


Intervention name(s): The domestic PCA equipment 'Accufuser Omnibus®'; Imported PCA equipment 'Infusor SV®, Baxter, USA'
Intervention type(s): Device; Device
Intervention description(s): Subject patient selection: the purpose and method of this research will be explained to the patients who satisfy the exclusion criteria before surgery, and written consent regarding research participation will be obtained.
Use of PCA equipment by patients is determined by randomization. Regardless of the PCA equipment type, the basal rate and bolus dose are equally set to 2 mL/hr and 2 mL for the entire research period.
Epidural PCA regime: normal saline added to 0.75% ropivacaine 40 mL and fentanyl 15-20 mcg/kg for a total volume of 100 ml.
After pretreatment, the chest epidural catheter is mounted in the pretreatment room or operating room. The catheter tip is adjusted to be fixed between T6-7 or T7-8.
After mounting the catheter, a test dose of 1% lidocaine 3 ml and epinephrine 1:200.000 is injected. Ten minutes later, sensory loss and skin dermatome will be checked using an alcohol swab.; Subject patient selection: the purpose and method of this research will be explained to the patients who satisfy the exclusion criteria before surgery, and written consent regarding research participation will be obtained.
Use of PCA equipment by patients is determined by randomization. Regardless of the PCA equipment type, the basal rate and bolus dose are equally set to 2 mL/hr and 2 mL for the entire research period.
Epidural PCA regime: normal saline added to 0.75% ropivacaine 40 mL and fentanyl 15-20 mcg/kg for a total volume of 100 ml.
After pretreatment, the chest epidural catheter is mounted in the pretreatment room or operating room. The catheter tip is adjusted to be fixed between T6-7 or T7-8.
After mounting the catheter, a test dose of 1% lidocaine 3 ml and epinephrine 1:200.000 is injected. Ten minutes later, sensory loss and skin dermatome will be checked using an alcohol swab.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Patient controlled analgesia equipment; efficacy; safety; Accufuser Omnibus®; Upper abdominal surgery; laparotomy