Gastric CancerPhase 4NCT01234272
Comparison of the Analgesic Effect Between Intrathecal Morphine and IV-fentanyl Patient Controlled Analgesia (ITM-IVPCA) and Epidural PCA (PCEA) in Patients Undergoing Gastrectomy -Randomized Allocation Study-
A Phase 4 study testing morphine and Ropivacaine in people with Gastric Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
The present study was designed to assess analgesic capacity of intrathecal administration of morphine combined with intravenous fentanyl patient-controlled analgesia (ITM-PCA) compared to patient controlled epidural analgesia using fentanyl and repivacaine (PCEA) in patients undergoing gastrectomy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- morphine and Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2010to Jun 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- I or II of preoperative physical status classification by the American Society of Anesthesiologists.
- more than 20 years old.
- undergoing gastrectomy due to gastric cancer.
Who cannot join
- contraindication to regional anesthesia technique (bleeding diasthesis, sepsis etc) or spine anomaly.
- prior history of abdominal surgery or spine surgery.
Trial locations and contacts
1 site in 1 country.
About this study
The present study was designed to assess analgesic capacity of intrathecal administration of morphine combined with intravenous fentanyl patient-controlled analgesia (ITM-PCA) compared to patient controlled epidural analgesia using fentanyl and repivacaine (PCEA) in patients undergoing gastrectomy. The investigators hypothesized that ITM-PCA would show comparable analgesic effect to PCEA in gastrectomy.
- Conditions
- Gastric Cancer
- Being tested
- morphine, Ropivacaine
- Keywords
- patients with, undergoing, gastrectomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
morphineDrug
ITM-IVPCA: intrathecal administration of 0.3 mg morphine before induction of general anesthesia and application of IVPCA (basal infusion: fentanyl 0.4mcg/kg/hr, bolus: 0.16mcg/kg of fentanyl with a lock out time of 15 min)
RopivacaineDrug
PCEA: epidural administration of 5ml 0.2% ropivacaine before induction of general anesthesia and application of PCEA (basal infusion: 5ml 0.2% ropivacaine with fentanyl 0.4 mcg/kg/hr, bolus: 2ml 0.2% ropivacaine with fentanyl 0.16mcg/kg with a lockout time 15min)
| Study group | Role | What they receive |
|---|---|---|
| ITM-IVPCA | Experimental | ITM-IVPCA:intrathecal morphine and IV-fentanyl patient controlled analgesia Receives: Drug: morphine |
| PCEA | Active comparator | PCEA:epidural PCA(patient controlled analgesia) Receives: Drug: Ropivacaine |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startAug 2010
- Primary completionJan 2011
- Study completionJun 2011
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Investigators
- Bon-Nyeo Koo, MD, Ph.D, Principal investigator, Severance Hospital, Department of Anesthesia and Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234272
- Sponsor's protocol ID
- 4-2010-0368
- Status last verified
- Aug 2011
- First submitted
- 3 Nov 2010
- Last updated
- 16 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Analgesic Effect Between Intrathecal Morphine and IV-fentanyl Patient Controlled Analgesia (ITM-IVPCA) and Epidural PCA (PCEA) in Patients Undergoing Gastrectomy -Randomized Allocation Study-
- ClinicalTrials.gov ID
- NCT01234272
- Acronym / sponsor ID
- 4-2010-0368
- Conditions
- Gastric Cancer
- Keywords
- patients with, undergoing, gastrectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 4 Nov 2010 (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 present study was designed to assess analgesic capacity of intrathecal administration of morphine combined with intravenous fentanyl patient-controlled analgesia (ITM-PCA) compared to patient controlled epidural analgesia using fentanyl and repivacaine (PCEA) in patients undergoing gastrectomy. The investigators hypothesized that ITM-PCA would show comparable analgesic effect to PCEA in gastrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ITM-IVPCA | Experimental | Drug: morphineITM-IVPCA:intrathecal morphine and IV-fentanyl patient controlled analgesia |
| PCEA | Active comparator | Drug: RopivacainePCEA:epidural PCA(patient controlled analgesia) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- I or II of preoperative physical status classification by the American Society of Anesthesiologists.
- more than 20 years old.
- undergoing gastrectomy due to gastric cancer.
Key exclusion criteria (2 listed)
- contraindication to regional anesthesia technique (bleeding diasthesis, sepsis etc) or spine anomaly.
- prior history of abdominal surgery or spine surgery.
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 |
|---|---|---|
| morphineITM-IVPCA: intrathecal administration of 0.3 mg morphine before induction of general anesthesia and application of IVPCA (basal infusion: fentanyl 0.4mcg/kg/hr, bolus: 0.16mcg/kg of fentanyl with a lock out time of 15 min) | Drug | ITM-IVPCA |
| RopivacainePCEA: epidural administration of 5ml 0.2% ropivacaine before induction of general anesthesia and application of PCEA (basal infusion: 5ml 0.2% ropivacaine with fentanyl 0.4 mcg/kg/hr, bolus: 2ml 0.2% ropivacaine with fentanyl 0.16mcg/kg with a lockout time 15min) | Drug | PCEA |
Primary outcome
Not reported in the source record.
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 16 Aug 2011.
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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.
Bon-Nyeo Koo, MD, Ph.D principal investigator
Severance Hospital, Department of Anesthesia and Pain Medicine
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 morphine and Ropivacaine 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 3 inclusion and 2 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 16 Aug 2011. 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.
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 16 Aug 2011.