Video-assisted Thoracoscopic SurgeryPhase 4NCT01917448
Low-dose Spinal Morphine for Post-Thoracotomy Pain After Video-Assisted Thoracoscopic Surgery
A Phase 4 study testing Morphine in people with Video-assisted Thoracoscopic Surgery, run by Mahidol University at 1 site in Thailand.
Trial summary
One-thirds of patients underwent video-assisted thorascopic surgery still have severe pain. Therefore we want to demonstrate weather 0.15 mg spinal morphine would reduce 24 hour postoperative requirement comparing to control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Video-assisted Thoracoscopic Surgery
- What is being tested?
- Morphine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2014to Jan 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
- ASA (American Society of Anesthesiologist) physical status I to III,
- Undergoing elective video-assisted thoracoscopic surgery at Siriraj and Thammasart Hospitals
- capable of using a patient-controlled analgesia (PCA) machine
- understanding the numeric rating scale (NRS) score for pain assessment.
Who cannot join
- history of allergy to the study drugs
- bleeding disorder
- infection of the back
- refusing spinal anesthesia
- history of cerebrovascular disease
- using postoperative ventilator support were excluded
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine, Siriraj Hospital, mahidol University
Bangkok, 10700
About this study
Official title: Low-dose Spinal Morphine for Post-Thoracotomy Pain After Video-Assisted Thoracoscopic Surgery: A Prospective Randomized Double-Blind Controlled Trial
One-thirds of patients underwent video-assisted thorascopic surgery still have severe pain. Therefore we want to demonstrate weather 0.15 mg spinal morphine would reduce 24 hour postoperative requirement comparing to control group.
- Conditions
- Video-assisted Thoracoscopic Surgery
- Being tested
- Morphine, control
- Keywords
- postoperative pain, spinal morphine, video-assisted thoracoscopic surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
spinal morphine 0.15 mg
controlOther
Patient receive only local infiltration without spinal analgesia
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | The skin will be injected with local anesthetic without spinal block Receives: Other: control |
| Spinal morphine | Active comparator | 0.15 mg spinal morphine Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total post-operative morphine requirement.
Measured: 48 hours
Secondary outcomes (1)
Pain after surgery
Measured: 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startFeb 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Video-assisted Thoracoscopic SurgeryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
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
- NCT01917448
- Sponsor's protocol ID
- 2556
- Status last verified
- Apr 2016
- First submitted
- 2 Aug 2013
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Spinal Morphine for Post-Thoracotomy Pain After Video-Assisted Thoracoscopic Surgery: A Prospective Randomized Double-Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT01917448
- Acronym / sponsor ID
- 2556
- Conditions
- Video-assisted Thoracoscopic Surgery
- Keywords
- postoperative pain, spinal morphine, video-assisted thoracoscopic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 6 Aug 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.
One-thirds of patients underwent video-assisted thorascopic surgery still have severe pain. Therefore we want to demonstrate weather 0.15 mg spinal morphine would reduce 24 hour postoperative requirement comparing to control group.
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 |
|---|---|---|
| Control | Sham comparator | Other: controlThe skin will be injected with local anesthetic without spinal block |
| Spinal morphine | Active comparator | Drug: Morphine0.15 mg 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)
- ASA (American Society of Anesthesiologist) physical status I to III,
- Undergoing elective video-assisted thoracoscopic surgery at Siriraj and Thammasart Hospitals
- capable of using a patient-controlled analgesia (PCA) machine
- understanding the numeric rating scale (NRS) score for pain assessment.
Key exclusion criteria (6 listed)
- history of allergy to the study drugs
- bleeding disorder
- infection of the back
- refusing 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 |
|---|---|---|
| Morphinespinal morphine 0.15 mg | Drug | Spinal morphine |
| controlPatient receive only local infiltration without spinal analgesia | Other | Control |
Primary outcome
Total post-operative morphine requirement.
Time frame: 48 hours
1 secondary outcome
Pain after surgery
Time frame: 48 hour
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 8 Apr 2016.
- Individual participant dataSharing planned: Undecided
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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 Morphine in people with Video-assisted Thoracoscopic Surgery, 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: finished, as of the sponsor's last update on 8 Apr 2016. 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. Some participants in this study may receive a placebo. 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?
Total post-operative morphine requirement. (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 8 Apr 2016.