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

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

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.

Study Overview

• Status: Unknown
• Conditions: Open Gastrectomy With Gastric Cancer
• Intervention / Treatment: Device: Apply CIPKA mode; Device: Conventional mode

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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. 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.
Active Comparator: Conventional mode; The conventional mode in which only the basal infusion rate is set to be fixed.	Device: Conventional mode; PCA pumps typically set a fixed basal infusion rate to set the analgesic to enter at a constant rate every hour (conventional mode).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Anticipated): November 11, 2020
• Study Completion (Anticipated): November 11, 2020

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (Actual): February 12, 2018

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 4-2016-1152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No