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

Open Gastrectomy With Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03430440
• Other study ID #: 4-2016-1152
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: November 11, 2020

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: Ki Young Lee, MD
• Phone: 82-02-2228-73997
• Email: KYLEE504[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: November 11, 2020
• Est. primary completion date: November 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

1. elective open gastrectomy due to stomach cancer

2. ASA classification ?-?

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

Related Conditions & MeSH terms

• Open Gastrectomy With Gastric Cancer
• Stomach Neoplasms

Intervention

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.
• 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).

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain (numerical rating scale: 0 ~ 10)		at 6 hours postoperatively
Secondary	Postoperative pain (numerical rating scale: 0 ~ 10)		at 1, 24, and 48 hours after surgery
Secondary	PCA total dose/additional analgesic dose		at 1, 6, 24, 48 hours after surgery
Secondary	Side effects of PCA (area and vomiting / hypotension / muscle weakness		at 1, 6, 24, 48 hours after surgery