Comparison of Analgesic Effects According to Patient-controlled Epidural Analgesia Modes in Patients Undergoing Open Gastrectomy

Study Overview
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Brief Summary
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Epidural PCA (patient controlled analgesia) for post-operative pain management are effective analgesic method. It is widely used in the postoperative pain management for decades. PCA pumps typically set a fixed basal infusion rate to infuse the analgesics at a constant rate per every hour (conventional mode). In contrast, the newly developed computer-integrated patient-controlled analgesia (CIPCA) mode increases or decreases the basal infusion rate with the use of the patient's bolus button. The CIPCA mode sets the basal infusion rate, the increase / decrease rate of basal rate, and the increment / decrement interval. If the patient presses the bolus button within the set time interval, the set infusion rate is increased because the analgesic is more required. If the bolus button is not pressed during the set time interval, the infusion rate is decreased. Therefore, it can be said that it is an effective method to control the dose of analgesic agent more sensitively to changes in patient's needs and pain.

Official Title
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Comparison of Analgesic Effects According to Patient-controlled Epidural Analgesia Modes in Patients Undergoing Open Gastrectomy: a Randomized Controlled Trial

Conditions
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Open Gastrectomy With Gastric Cancer

Intervention / Treatment
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* Device: Apply CIPKA mode
* Device: Conventional mode


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective open gastrectomy due to stomach cancer ASA classification Ⅰ-Ⅲ Exclusion Criteria: hematologic clotting defect sepsis distance metastasis PCA drug (fentanyl, Ropivacaine) allergy Patients who can not read the consent form or are not fluent in Korean (illiterate, foreigner) pregnant, lactating women

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CIPKA mode<br>The newly developed computer-integrated patient-controlled analgesia (CIPCA) mode increases or decreases the basal infusion rate with the use of the patient's bolus button. | Device: Apply CIPKA mode<br>* The newly developed computer-integrated patient-controlled analgesia (CIPCA) mode increases or decreases the basal infusion rate with the use of the patient's bolus button. Compared with the conventional mode in which only the basal infusion rate is set to be fixed, the CIPCA mode sets the basal infusion rate, the increase / decrease rate of basal rate, and the increment / decrement interval.<br>|
| Active Comparator: Conventional mode<br>The conventional mode in which only the basal infusion rate is set to be fixed. | Device: Conventional mode<br>* PCA pumps typically set a fixed basal infusion rate to set the analgesic to enter at a constant rate every hour (conventional mode).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain (numerical rating scale: 0   10) |  | at 6 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain (numerical rating scale: 0   10) |  | at 1, 24, and 48 hours after surgery | 
| PCA total dose/additional analgesic dose |  | at 1, 6, 24, 48 hours after surgery | 
| Side effects of PCA (area and vomiting / hypotension / muscle weakness |  | at 1, 6, 24, 48 hours after surgery |