Skip to main content
Clinical Trials/NCT03430440
NCT03430440
Unknown
Not Applicable

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

Yonsei University1 site in 1 country76 target enrollmentMarch 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Open Gastrectomy With Gastric Cancer
Sponsor
Yonsei University
Enrollment
76
Locations
1
Primary Endpoint
Postoperative pain (numerical rating scale: 0 ~ 10)
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2017
End Date
November 11, 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • elective open gastrectomy due to stomach cancer
  • ASA classification Ⅰ-Ⅲ

Exclusion Criteria

  • hematologic clotting defect
  • 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

Outcomes

Primary Outcomes

Postoperative pain (numerical rating scale: 0 ~ 10)

Time Frame: at 6 hours postoperatively

Secondary Outcomes

  • 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)

Study Sites (1)

Loading locations...

Similar Trials