Solitary MassPhase 4painNCT01236495
Comparison for Pethidine Requirement in Patients Received Spinal Morphine 0.2 and 0.3 mg for Post Lobectomy Analgesia
A Phase 4 study testing spinal morphine 0.3 mg and spinal morphine 0.2 mg in people with Solitary Mass and Lung Diseases, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of the study is to evaluate the amount of total pethidine requirement during the 48 hour postoperative period after receiving spinal morphine 0.2 and 0.3 mg. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Solitary Mass, Lung Diseases
- What is being tested?
- spinal morphine 0.3 mg and spinal morphine 0.2 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2010to Mar 2012
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 year and < 70 year
- Patient ASA physical status I-III.
- Scheduled for thoracotomy with lobectomy.
- Can operate a patient-controlled analgesia (PCA) device.
Who cannot join
- Known hypersensitivity to morphine or pethidine
- History of bleeding tendency.
- Known case of infection at the back
- Patient refuse for spinal anesthesia
- History of cerebrovascular disease.
- Scheduled for video-assisted thoracoscopic lobectomy.
- Need mechanical ventilatory support during postoperative period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison for Pethidine Requirement in Patients Received Spinal Morphine 0.2 and 0.3 Milligram for Post Lobectomy (Lung) Analgesia
The purpose of the study is to evaluate the amount of total pethidine requirement during the 48 hour postoperative period after receiving spinal morphine 0.2 and 0.3 mg.
Read the detailed description
Thoracotomy causes severe pain to the patients. Continuous thoracic epidural is a gold standard for postoperative pain. However, it needs skill. There are many alternatives such as spinal morphine, intercostal nerve block, cryoalangesia or interpleural block.
- Conditions
- Solitary Mass, Lung Diseases
- Being tested
- spinal morphine 0.3 mg, spinal morphine 0.2 mg
- Keywords
- thoracotomy, postoperative pain, spinal morphine
- Medical subject headings
- Lung Diseases, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal morphine 0.3 mgDrug
Also called morphine
spinal morphine 0.3 mg
spinal morphine 0.2 mgDrug
Also called morphine
spinal morphine 0.2 mg
| Study group | Role | What they receive |
|---|---|---|
| spinal morphine 0.2 mg | Experimental | spinal morphine 0.2 mg Receives: Drug: spinal morphine 0.2 mg |
| spinal morphine 0.3 mg | Active comparator | spinal morphine 0.3 mg Receives: Drug: spinal morphine 0.3 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
pethidine requirement
Total pethidine requirement during 48 hours postoperative
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 2010 (estimated)
- Study startNov 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solitary MassStudies 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 (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, M.D., Principal investigator, Deaprt ment of Anesthesiology ,Faculty of Medicine, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236495
- Sponsor's protocol ID
- si578/2010
- Acronym
- pain
- Status last verified
- Mar 2012
- First submitted
- 5 Nov 2010
- Last updated
- 13 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison for Pethidine Requirement in Patients Received Spinal Morphine 0.2 and 0.3 Milligram for Post Lobectomy (Lung) Analgesia
- ClinicalTrials.gov ID
- NCT01236495
- Acronym / sponsor ID
- pain / si578/2010
- Conditions
- Solitary Mass, Lung Diseases
- Keywords
- thoracotomy, postoperative pain, spinal morphine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 8 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 purpose of the study is to evaluate the amount of total pethidine requirement during the 48 hour postoperative period after receiving spinal morphine 0.2 and 0.3 mg.
Detailed description
Thoracotomy causes severe pain to the patients. Continuous thoracic epidural is a gold standard for postoperative pain. However, it needs skill. There are many alternatives such as spinal morphine, intercostal nerve block, cryoalangesia or interpleural block.
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 0.2 mg | Experimental | Drug: spinal morphine 0.2 mgspinal morphine 0.2 mg |
| spinal morphine 0.3 mg | Active comparator | Drug: spinal morphine 0.3 mgspinal morphine 0.3 mg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 year and < 70 year
- Patient ASA physical status I-III.
- Scheduled for thoracotomy with lobectomy.
- Can operate a patient-controlled analgesia (PCA) device.
Key exclusion criteria (7 listed)
- Known hypersensitivity to morphine or pethidine
- 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 morphine 0.3 mgAlso: morphinespinal morphine 0.3 mg | Drug | spinal morphine 0.3 mg |
| spinal morphine 0.2 mgAlso: morphinespinal morphine 0.2 mg | Drug | spinal morphine 0.2 mg |
Primary outcome
pethidine requirement
Time frame: 48 hours
Total pethidine requirement during 48 hours postoperative
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 13 Mar 2012.
Related trials for Solitary Mass
RecruitingPhase 1
Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 After a Single Oral Dose
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Not yet recruitingPhase 1
The Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]OD-001 in Healthy Male Participants
Health Volunteers
RecruitingPhase 2
Intravenous Fish Oil Emulsion in Critically Ill Patients With High Inflammatory Status.
Critical Illness
Recruiting
ENLIGHT Trial: ESG With Fundal Mucosal Ablation
Obesity, Obesity (Body Mass Index >30 kg/m2)
Not yet recruitingPhase 1
A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults
Schizophrenia
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, M.D. principal investigator
Deaprt ment of Anesthesiology ,Faculty of Medicine, Siriraj Hospital
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 0.3 mg and spinal morphine 0.2 mg in people with Solitary Mass and Lung Diseases, 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 7 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 13 Mar 2012. 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?
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?
pethidine 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 13 Mar 2012.