Postoperative PainPhase 4NCT01979354
0.15 mg Spinal Morphine vs. no Treatment for Morphine Requirement After VATs.
A Phase 4 study testing Spinal morphine in people with Postoperative Pain, run by Mahidol University at 1 site in Thailand.
Trial summary
Postoperative pain after Video-assisted Thoracoscopic Surgery (VAT) is still debating. Therefore the investigators conduct a study comparing 0.15 mg spinal morphine and control group in term of analgesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Spinal morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2014to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 year or over
- Patient ASA physical status I-III.
- Scheduled for video-assisted thoracoscopic lobectomy or blebectomy with pleurectomy or pleural abrasion
- Can operate a patient-controlled analgesia (PCA) device.
Who cannot join
- Known hypersensitivity to morphine
- History of bleeding tendency.
- Known case of infection at the back
- Patient refuse for spinal anesthesia
- History of cerebrovascular disease.
- Need mechanical ventilatory support during postoperative period
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Mahidol University
Bangkok, 10700
Sirilak Suksompong, MD, 6624113256, sirilak.suk@mahidol.ac.th
Sirilak Suksompong, MD
About this study
Official title: The Comparison of 0.15 Milligram Spinal Morphine vs.no Treatment for Morphine Requirement After Video-assisted Thoracoscopic Surgery. A Pilot Randomized Control Study
Postoperative pain after Video-assisted Thoracoscopic Surgery (VAT) is still debating. Therefore the investigators conduct a study comparing 0.15 mg spinal morphine and control group in term of analgesia.
- Conditions
- Postoperative Pain
- Being tested
- Spinal morphine
- Keywords
- spinal morphine, VATs lobectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal morphineDrug
0.15 mg spinal morphine
| Study group | Role | What they receive |
|---|---|---|
| Spinal morphine | Active comparator | 0.15 mg spinal morphine Receives: Drug: Spinal morphine |
| Control | No intervention | No spinal morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine requirement in 48 hours
Measured: 48 hours
Secondary outcomes (1)
Pain
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startFeb 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sirilak Suksompong, Mahidol University
- Investigators
- Sirilak Suksompong, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979354
- Sponsor's protocol ID
- 552/2556(EC3)
- Status last verified
- Nov 2015
- First submitted
- 2 Nov 2013
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of 0.15 Milligram Spinal Morphine vs.no Treatment for Morphine Requirement After Video-assisted Thoracoscopic Surgery. A Pilot Randomized Control Study
- ClinicalTrials.gov ID
- NCT01979354
- Acronym / sponsor ID
- 552/2556(EC3)
- Conditions
- Postoperative Pain
- Keywords
- spinal morphine, VATs lobectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 8 Nov 2013 (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.
Postoperative pain after Video-assisted Thoracoscopic Surgery (VAT) is still debating. Therefore the investigators conduct a study comparing 0.15 mg spinal morphine and control group in term of analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal morphine | Active comparator | Drug: Spinal morphine0.15 mg spinal morphine |
| Control | No intervention | –No spinal morphine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 year or over
- Patient ASA physical status I-III.
- Scheduled for video-assisted thoracoscopic lobectomy or blebectomy with pleurectomy or pleural abrasion
- Can operate a patient-controlled analgesia (PCA) device.
Key exclusion criteria (6 listed)
- Known hypersensitivity to morphine
- History of bleeding tendency.
- Known case of infection at the back
- Patient refuse for spinal anesthesia
- History of cerebrovascular disease.
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 |
|---|---|---|
| Spinal morphine0.15 mg spinal morphine | Drug | Spinal morphine |
Primary outcome
Total morphine requirement in 48 hours
Time frame: 48 hours
1 secondary outcome
Pain
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 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.
Sirilak Suksompong, MD principal investigator
Mahidol University
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 Spinal morphine in people with Postoperative Pain, run by Mahidol University at 1 site in Thailand.
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 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 10 Nov 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine requirement in 48 hours (time frame: 48 hours). 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 10 Nov 2015.