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

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ClinicalTrials.gov Identifier: NCT03430440
Recruitment Status : Not yet recruiting
First Posted : February 12, 2018
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Open Gastrectomy With Gastric Cancer Device: Apply CIPKA mode Device: Conventional mode

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Analgesic Effects According to Patient-controlled Epidural Analgesia Modes in Patients Undergoing Open Gastrectomy: a Randomized Controlled Trial
Anticipated Study Start Date : March 1, 2018
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : November 15, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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).



Primary Outcome Measures :
  1. Postoperative pain (numerical rating scale: 0 ~ 10) [ Time Frame: at 6 hours postoperatively ]

Secondary Outcome Measures :
  1. Postoperative pain (numerical rating scale: 0 ~ 10) [ Time Frame: at 1, 24, and 48 hours after surgery ]
  2. PCA total dose/additional analgesic dose [ Time Frame: at 1, 6, 24, 48 hours after surgery ]
  3. Side effects of PCA (area and vomiting / hypotension / muscle weakness [ Time Frame: at 1, 6, 24, 48 hours after surgery ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430440


Contacts
Contact: Ki Young Lee, MD 82-02-2228-73997 KYLEE504@yuhs.ac

Sponsors and Collaborators
Yonsei University

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03430440     History of Changes
Other Study ID Numbers: 4-2016-1152
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs