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

Primary Purpose

Open Gastrectomy With Gastric Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Apply CIPKA mode

Conventional mode

About this trial

This is an interventional treatment trial for Open Gastrectomy With Gastric Cancer

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CIPKA mode

Conventional mode

Arm Description

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 conventional mode in which only the basal infusion rate is set to be fixed.

Outcomes

Primary Outcome Measures

Postoperative pain (numerical rating scale: 0 ~ 10)

Secondary Outcome Measures

Postoperative pain (numerical rating scale: 0 ~ 10)

PCA total dose/additional analgesic dose

Side effects of PCA (area and vomiting / hypotension / muscle weakness

Full Information

NCT ID

NCT03430440

First Posted

February 5, 2018

Last Updated

January 14, 2019

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT03430440

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2017 (Actual)

Primary Completion Date

November 11, 2020 (Anticipated)

Study Completion Date

November 11, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Open Gastrectomy With Gastric Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CIPKA mode

Arm Type

Experimental

Arm Description

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.

Arm Title

Conventional mode

Arm Type

Active Comparator

Arm Description

The conventional mode in which only the basal infusion rate is set to be fixed.

Intervention Type

Device

Intervention Name(s)

Apply CIPKA mode

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Conventional mode

Intervention Description

PCA pumps typically set a fixed basal infusion rate to set the analgesic to enter at a constant rate every hour (conventional mode).

Primary Outcome Measure Information:

Title

Postoperative pain (numerical rating scale: 0 ~ 10)

Time Frame

at 6 hours postoperatively

Secondary Outcome Measure Information:

Title

Postoperative pain (numerical rating scale: 0 ~ 10)

Time Frame

at 1, 24, and 48 hours after surgery

Title

PCA total dose/additional analgesic dose

Time Frame

at 1, 6, 24, 48 hours after surgery

Title

Side effects of PCA (area and vomiting / hypotension / muscle weakness

Time Frame

at 1, 6, 24, 48 hours after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ki Young Lee, MD

Phone

82-02-2228-73997

KYLEE504@yuhs.ac

Facility Information:

Facility Name

Severance Hospital

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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