NCT03430440

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

Status unknown NA Last updated 15 January 2019

What this trial tests

NA trial testing Apply CIPKA mode in Open Gastrectomy With Gastric Cancer in 76 participants. Status unknown.

Timeline

1 March 2017

Primary endpoint
11 November 2020

11 November 2020

Quick facts

Lead sponsor	Yonsei University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	76
Start date	1 March 2017
Primary completion	11 November 2020
Estimated completion	11 November 2020
Sites	1 location across South Korea

Drugs / interventions tested

• Apply CIPKA mode
• Conventional mode

Conditions studied

• Open Gastrectomy With Gastric Cancer — all drugs for Open Gastrectomy With Gastric Cancer →

Sponsor

Yonsei University

Who can join

Adults 20 to 70, any sex, with Open Gastrectomy With Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison of Postoperative Pain and Adverse Effects between Variable-Rate Feedback Infusion and Conventional Fixed-Rate Basal Infusion Modes of Patient-Controlled Epidural Analgesia following Open Gastrectomy: A Randomized Controlled Trial.
   Jang YK, Kim NY, Lee JS, Shin HJ, et al · · 2021 · cited 3× · PMID 34444526 · DOI 10.3390/ijerph18168777