Gastric CancerPhase 3NCT02444897
The Comparison Between Epidural and Intravenous Patient-controlled Analgesia for Laparoscopic Gastrectomy
A Phase 3 study testing Epidural PCA Ropivacaine and IV PCA Fentanyl+nefopam+Ramosetron in people with Gastric Cancer, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial summary
This study was designed to assess the effectiveness of epidural patient-controlled analgesia compared to intravenous patient-controlled analgesia in patients undergoing laparoscopic gastrectomy. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Epidural PCA Ropivacaine and IV PCA Fentanyl+nefopam+Ramosetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to Dec 2014
- Phase
- Phase 3
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma in stomach
- Males or Females, aged≥19 years and ≤80 years
- Scheduled as laparoscopic gastrectomy
- Patient has given their written informed consent to participate in the study
Who cannot join
- History of hypersensitivity for analgesics
- Recent history of narcotic analgesics
- Disability of central nerve system
- Uncontrolled co-morbidity
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Keimyung University Dongsan Medical Center
Daegu, 700-712
About this study
This study was designed to assess the effectiveness of epidural patient-controlled analgesia compared to intravenous patient-controlled analgesia in patients undergoing laparoscopic gastrectomy. The investigators hypothesized that epidural PCA would be more effective in pain control than IV PCA even for laparoscopic gastrectomy.
- Conditions
- Gastric Cancer
- Being tested
- Epidural PCA Ropivacaine, IV PCA Fentanyl+nefopam+Ramosetron
- Keywords
- Gastric cancer, epidural, PCA, laparoscopy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural PCA RopivacaineDrug
Also called Epidural patient-controlled analgesia Ropivacaine
Epidural catheter insertion at T10 level before surgery, the tip of catheter location at T8-9 level.
Total volume: 500ml, 16.7mcg/kg+0.75% Ropivacaine 80ml+N/S
IV PCA Fentanyl+nefopam+RamosetronDrug
Also called intravenous patient-controlled analgesia
Total volume: 84ml, Fentanyl 1000mcg+nefopam 120mg+Ramosetron 0.3mg Basal infusion: 1ml/hr, Bolus: 0.5ml with a lockout time 15min.
| Study group | Role | What they receive |
|---|---|---|
| Epidural PCA group | Experimental | Epidural patient-controlled analgesia group Receives: Drug: Epidural PCA Ropivacaine |
| IV PCA group | Active comparator | Intravenous patient-controlled analgesia Receives: Drug: IV PCA Fentanyl+nefopam+Ramosetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score
pain degree was checked at every 24hours for 5days after operation
Measured: 24 hours after operation
Secondary outcomes (2)
number of participants with complication
PCA related complication
Measured: for 5days after operation
Bowel motility
by counting Colomark on abdomen x-ray
Measured: for 5days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startSep 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung Wan Ryu, Keimyung University Dongsan Medical Center
- Investigators
- Seung Wan Ryu, M.D., Ph.D., Principal investigator, Director of gastrointestinal surgery devision, associate proffessor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444897
- Sponsor's protocol ID
- 2012-12-514
- Status last verified
- May 2015
- First submitted
- 25 Apr 2015
- Last updated
- 15 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison Between Epidural and Intravenous Patient-controlled Analgesia for Laparoscopic Gastrectomy
- ClinicalTrials.gov ID
- NCT02444897
- Acronym / sponsor ID
- 2012-12-514
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, epidural, PCA, laparoscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 May 2015 (estimated)
- 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.
This study was designed to assess the effectiveness of epidural patient-controlled analgesia compared to intravenous patient-controlled analgesia in patients undergoing laparoscopic gastrectomy. The investigators hypothesized that epidural PCA would be more effective in pain control than IV PCA even for laparoscopic gastrectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural PCA group | Experimental | Drug: Epidural PCA RopivacaineEpidural patient-controlled analgesia group |
| IV PCA group | Active comparator | Drug: IV PCA Fentanyl+nefopam+RamosetronIntravenous patient-controlled analgesia |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed adenocarcinoma in stomach
- Males or Females, aged≥19 years and ≤80 years
- Scheduled as laparoscopic gastrectomy
- Patient has given their written informed consent to participate in the study
Key exclusion criteria (4 listed)
- History of hypersensitivity for analgesics
- Recent history of narcotic analgesics
- Disability of central nerve system
- Uncontrolled co-morbidity
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 |
|---|---|---|
| Epidural PCA RopivacaineAlso: Epidural patient-controlled analgesia RopivacaineEpidural catheter insertion at T10 level before surgery, the tip of catheter location at T8-9 level. Total volume: 500ml, 16.7mcg/kg+0.75% Ropivacaine 80ml+N/S | Drug | Epidural PCA group |
| IV PCA Fentanyl+nefopam+RamosetronAlso: intravenous patient-controlled analgesiaTotal volume: 84ml, Fentanyl 1000mcg+nefopam 120mg+Ramosetron 0.3mg Basal infusion: 1ml/hr, Bolus: 0.5ml with a lockout time 15min. | Drug | IV PCA group |
Primary outcome
VAS score
Time frame: 24 hours after operation
pain degree was checked at every 24hours for 5days after operation
2 secondary outcomes
number of participants with complication
Time frame: for 5days after operation
Bowel motility
Time frame: for 5days after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
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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.
Seung Wan Ryu, M.D., Ph.D. principal investigator
Director of gastrointestinal surgery devision, associate proffessor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epidural PCA Ropivacaine and IV PCA Fentanyl+nefopam+Ramosetron in people with Gastric Cancer, run by Keimyung University Dongsan Medical Center 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 15 May 2015. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score (time frame: 24 hours after operation). 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 May 2015; AzTrials last refreshed its copy on 6 Nov 2026.