Gastric CancerPhase 4NCT02458573
Comparison of the Effects of Continuous Epidural Analgesia and Continuous Intravenous Analgesia on Postoperative Bowel Movement in Patients Undergoing Laparoscopic Gastrectomy
A Phase 4 study testing continuous epidural analgesia and continuous intravenous analgesia in people with Gastric Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
The investigators hypothesized that sympatholytic effect of epidural analgesia would attenuate the hemodynamic instability and decrease in the splanchnic blood flow caused by pneumoperitoneum during laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- continuous epidural analgesia and continuous intravenous analgesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Jun 2015to 28 Mar 2016
- Phase
- Phase 4
- 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
- patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅲ
- gastric cancer patient undergoing laparoscopic gastrectomy
Who cannot join
- ASA physical status Ⅳ
- bradycardia (< 60 bpm), arrhythmia
- uncompensated heart failure
- hepatic failure (Child-Pugh score B)
- renal failure (eGFR MDRD < 60 ml/min/1.73m2)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, Seoul, 150-752
About this study
The investigators hypothesized that sympatholytic effect of epidural analgesia would attenuate the hemodynamic instability and decrease in the splanchnic blood flow caused by pneumoperitoneum during laparoscopic surgery. This study is to compare the effect of epidural analgesia and intravenous analgesia on postoperative bowel movement in patients undergoing laparoscopic gastrectomy.
- Conditions
- Gastric Cancer
- Being tested
- continuous epidural analgesia, continuous intravenous analgesia
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous epidural analgesiaOther
the continuous epidural analgesia group: epidural analgesia started from induction of anesthesia and continued for 48 h.
continuous intravenous analgesiaOther
the continuous intravenous analgesia group: intravenous analgesia started from induction of anesthesia and continued for 48 h.
| Study group | Role | What they receive |
|---|---|---|
| continuous epidural analgesia group | Experimental | Not described Receives: Other: continuous epidural analgesia |
| continuous intravenous analgesia group | Active comparator | Not described Receives: Other: continuous intravenous analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time to first gas passing after surgery
Outcome will be assessed by a investigator blinded to the study group.
Measured: within 5days after surgery
the time to resume water intake after surgery
Outcome will be assessed by a investigator blinded to the study group.
Measured: within 5days after surgery
soft diet intake after surgery
Outcome will be assessed by a investigator blinded to the study group.
Measured: within 5days after surgery
Secondary outcomes (1)
postoperative pain
numerical rating scale 0 (no pain) to 10 (worst pain)
Measured: immediately after surgery to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study start4 Jun 2015
- Primary completion28 Mar 2016
- Study completion28 Mar 2016
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.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458573
- Sponsor's protocol ID
- 4-2015-0157
- Status last verified
- Jan 2017
- First submitted
- 26 May 2015
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Continuous Epidural Analgesia and Continuous Intravenous Analgesia on Postoperative Bowel Movement in Patients Undergoing Laparoscopic Gastrectomy
- ClinicalTrials.gov ID
- NCT02458573
- Acronym / sponsor ID
- 4-2015-0157
- Conditions
- Gastric Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 4 Jun 2015 (actual)
- Primary completion
- 28 Mar 2016 (actual)
- Study completion
- 28 Mar 2016 (actual)
- First posted
- 1 Jun 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.
The investigators hypothesized that sympatholytic effect of epidural analgesia would attenuate the hemodynamic instability and decrease in the splanchnic blood flow caused by pneumoperitoneum during laparoscopic surgery. This study is to compare the effect of epidural analgesia and intravenous analgesia on postoperative bowel movement in patients undergoing laparoscopic gastrectomy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continuous epidural analgesia group | Experimental | Other: continuous epidural analgesia |
| continuous intravenous analgesia group | Active comparator | Other: continuous intravenous analgesia |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅲ
- gastric cancer patient undergoing laparoscopic gastrectomy
Key exclusion criteria (5 listed)
- ASA physical status Ⅳ
- bradycardia (< 60 bpm), arrhythmia
- uncompensated heart failure
- hepatic failure (Child-Pugh score B)
- renal failure (eGFR MDRD < 60 ml/min/1.73m2)
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 |
|---|---|---|
| continuous epidural analgesiathe continuous epidural analgesia group: epidural analgesia started from induction of anesthesia and continued for 48 h. | Other | continuous epidural analgesia group |
| continuous intravenous analgesiathe continuous intravenous analgesia group: intravenous analgesia started from induction of anesthesia and continued for 48 h. | Other | continuous intravenous analgesia group |
Primary outcome
the time to first gas passing after surgery
Time frame: within 5days after surgery
Outcome will be assessed by a investigator blinded to the study group.
the time to resume water intake after surgery
Time frame: within 5days after surgery
Outcome will be assessed by a investigator blinded to the study group.
soft diet intake after surgery
Time frame: within 5days after surgery
Outcome will be assessed by a investigator blinded to the study group.
1 secondary outcome
postoperative pain
Time frame: immediately after surgery to 48 hours
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 25 Jan 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing continuous epidural analgesia and continuous intravenous analgesia in people 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 5 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 25 Jan 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
the time to first gas passing after surgery (time frame: within 5days after surgery). The study lists 3 primary outcomes in all. 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 25 Jan 2017.