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

Not Applicable

• Conditions: Open Gastrectomy With Gastric Cancer
• Interventions: Device: Conventional mode; Device: Apply CIPKA mode

• Registration Number: NCT03430440
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2018-02-05
• Study First Submitted QC: 2018-02-05
• Study First Posted: 2018-02-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-15
• Primary Completion: 2020-11-11
• Study Completion: 2020-11-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

1. elective open gastrectomy due to stomach cancer
2. ASA classification Ⅰ-Ⅲ

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Exclusion Criteria

1. hematologic clotting defect
2. sepsis
3. distance metastasis
4. PCA drug (fentanyl, Ropivacaine) allergy
5. Patients who can not read the consent form or are not fluent in Korean (illiterate, foreigner)
6. pregnant, lactating women

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional mode	Conventional mode	The conventional mode in which only the basal infusion rate is set to be fixed.
CIPKA mode	Apply CIPKA mode	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.

Primary Outcome Measures

Name	Time	Method
Postoperative pain (numerical rating scale: 0 ~ 10)	at 6 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
PCA total dose/additional analgesic dose	at 1, 6, 24, 48 hours after surgery
Postoperative pain (numerical rating scale: 0 ~ 10)	at 1, 24, and 48 hours after surgery
Side effects of PCA (area and vomiting / hypotension / muscle weakness	at 1, 6, 24, 48 hours after surgery

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of