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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03430440
Enrollment
76
Registered
2018-02-12
Start date
2017-03-01
Completion date
2020-11-11
Last updated
2019-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open Gastrectomy With Gastric Cancer

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.

Interventions

DEVICEConventional mode

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

DEVICEApply 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.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Postoperative pain (numerical rating scale: 0 ~ 10)at 6 hours postoperatively

Secondary

MeasureTime frame
Postoperative pain (numerical rating scale: 0 ~ 10)at 1, 24, and 48 hours after surgery
PCA total dose/additional analgesic doseat 1, 6, 24, 48 hours after surgery
Side effects of PCA (area and vomiting / hypotension / muscle weaknessat 1, 6, 24, 48 hours after surgery

Countries

South Korea

Contacts

Primary ContactKi Young Lee, MD
KYLEE504@yuhs.ac82-02-2228-73997

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026