Open Gastrectomy With Gastric CancerNCT03430440
Comparison of Analgesic Effects According to Patient-controlled Epidural Analgesia Modes in Patients Undergoing Open Gastrectomy
A study testing Apply CIPKA mode and Conventional mode in people with Open Gastrectomy With Gastric Cancer, run by Yonsei University at 1 site in South Korea.
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). Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Open Gastrectomy With Gastric Cancer
- What is being tested?
- Apply CIPKA mode and Conventional mode
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2017to 11 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective open gastrectomy due to stomach cancer
- ASA classification Ⅰ-Ⅲ
Who cannot join
- hematologic clotting defect
- sepsis
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Analgesic Effects According to Patient-controlled Epidural Analgesia Modes in Patients Undergoing Open Gastrectomy: a Randomized Controlled Trial
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.
- Conditions
- Open Gastrectomy With Gastric Cancer
- Being tested
- Apply CIPKA mode, Conventional mode
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apply CIPKA modeDevice
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 modeDevice
PCA pumps typically set a fixed basal infusion rate to set the analgesic to enter at a constant rate every hour (conventional mode).
| Study group | Role | What they receive |
|---|---|---|
| CIPKA mode | Experimental | 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. Receives: Device: Apply CIPKA mode |
| Conventional mode | Active comparator | The conventional mode in which only the basal infusion rate is set to be fixed. Receives: Device: Conventional mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain (numerical rating scale: 0 ~ 10)
Measured: at 6 hours postoperatively
Secondary outcomes (3)
Postoperative pain (numerical rating scale: 0 ~ 10)
Measured: at 1, 24, and 48 hours after surgery
PCA total dose/additional analgesic dose
Measured: at 1, 6, 24, 48 hours after surgery
Side effects of PCA (area and vomiting / hypotension / muscle weakness
Measured: at 1, 6, 24, 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start1 Mar 2017
- Primary completion11 Nov 2020 (estimated)
- Study completion11 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Gastrectomy With Gastric CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430440
- Sponsor's protocol ID
- 4-2016-1152
- Status last verified
- Jan 2019
- First submitted
- 5 Feb 2018
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Effects According to Patient-controlled Epidural Analgesia Modes in Patients Undergoing Open Gastrectomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03430440
- Acronym / sponsor ID
- 4-2016-1152
- Conditions
- Open Gastrectomy With Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 11 Nov 2020 (estimated)
- Study completion
- 11 Nov 2020 (estimated)
- First posted
- 12 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIPKA mode | Experimental | Device: Apply CIPKA modeThe 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. |
| Conventional mode | Active comparator | Device: Conventional modeThe conventional mode in which only the basal infusion rate is set to be fixed. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- elective open gastrectomy due to stomach cancer
- ASA classification Ⅰ-Ⅲ
Key exclusion criteria (6 listed)
- hematologic clotting defect
- sepsis
- distance metastasis
- PCA drug (fentanyl, Ropivacaine) allergy
- Patients who can not read the consent form or are not fluent in Korean (illiterate, foreigner)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apply CIPKA modeThe 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. | Device | CIPKA mode |
| Conventional modePCA pumps typically set a fixed basal infusion rate to set the analgesic to enter at a constant rate every hour (conventional mode). | Device | Conventional mode |
Primary outcome
Postoperative pain (numerical rating scale: 0 ~ 10)
Time frame: at 6 hours postoperatively
3 secondary outcomes
Postoperative pain (numerical rating scale: 0 ~ 10)
Time frame: at 1, 24, and 48 hours after surgery
PCA total dose/additional analgesic dose
Time frame: at 1, 6, 24, 48 hours after surgery
Side effects of PCA (area and vomiting / hypotension / muscle weakness
Time frame: at 1, 6, 24, 48 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apply CIPKA mode and Conventional mode in people with Open Gastrectomy With Gastric Cancer, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ki Young Lee, MD (82-02-2228-73997, KYLEE504@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (numerical rating scale: 0 ~ 10) (time frame: at 6 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019; AzTrials last refreshed its copy on 8 Nov 2026.