MorphinePhase 4NCT02067338
Epidural Low Dose Morphine in Postoperative Pain After Posterior Lumbar Spinal Surgery
A Phase 4 study testing 1 mg morphine soak in epidural oxidized cellulose and normal saline in people with Morphine, run by Mahidol University at 1 site in Thailand.
Trial summary
The effect of epidural low-dose morphine-soaked microfibrillar collagen sponge in postoperative pain control after posterior lumbar spinal surgery: a randomized, double-blind, placebo-controlled study Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Morphine
- What is being tested?
- 1 mg morphine soak in epidural oxidized cellulose and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2012to Jan 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 Yrs
- Good orientation and communication
Who cannot join
- opioids or sulfonamides allergy
- Contraindication for use
- Epidural morphine
- Selective COX 2 inhibitor
- Patient-controlled analgesia (PCA)
- ASA class > 3
Show all 9Show fewer
- BMI ≥ 35 kg/sq.m.
- Preoperative use of opioids within 6 Wks
- Intraoperative bleeding > 1000ml
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Epidural Low-dose Morphine-soaked Microfibrillar Collagen Sponge in Postoperative Pain Control After Posterior Lumbar Spinal Surgery: a Randomized, Double-blind, Placebo-controlled
The effect of epidural low-dose morphine-soaked microfibrillar collagen sponge in postoperative pain control after posterior lumbar spinal surgery: a randomized, double-blind, placebo-controlled study
- Conditions
- Morphine
- Being tested
- 1 mg morphine soak in epidural oxidized cellulose, normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 mg morphine soak in epidural oxidized celluloseDrug
During posterior lumbar spinal surgery , patients received 1 mg morphine-soaked in epidural oxidized cellulose.
normal salineDrug
During posterior lumbar spinal surgery , patients received NSS -soaked in epidural oxidized cellulose.
| Study group | Role | What they receive |
|---|---|---|
| normal saline | Placebo comparator | During posterior lumbar spinal surgery,one group of patient received normal saline soaked collagen sponge. Receives: Drug: normal saline |
| 1 mg morphine soak in epidural oxidized cellulose | Active comparator | During posterior lumbar spinal surgery ,Another group of patients received 1 mg morphine-soaked in epidural oxidized cellulose. Receives: Drug: 1 mg morphine soak in epidural oxidized cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS measurement was recorded at twenty-four hour after posterior lumbar spinal surgery then compare VAS between low-dose 1 mg morphine-soaked microfibrillar collagen sponge method with normal saline soked
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startAug 2012
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MorphineStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067338
- Sponsor's protocol ID
- SI 387/2012
- Status last verified
- Feb 2014
- First submitted
- 9 Feb 2014
- Last updated
- 20 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Epidural Low-dose Morphine-soaked Microfibrillar Collagen Sponge in Postoperative Pain Control After Posterior Lumbar Spinal Surgery: a Randomized, Double-blind, Placebo-controlled
- ClinicalTrials.gov ID
- NCT02067338
- Acronym / sponsor ID
- SI 387/2012
- Conditions
- Morphine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 20 Feb 2014 (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 effect of epidural low-dose morphine-soaked microfibrillar collagen sponge in postoperative pain control after posterior lumbar spinal surgery: a randomized, double-blind, placebo-controlled study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal saline | Placebo comparator | Drug: normal salineDuring posterior lumbar spinal surgery,one group of patient received normal saline soaked collagen sponge. |
| 1 mg morphine soak in epidural oxidized cellulose | Active comparator | Drug: 1 mg morphine soak in epidural oxidized celluloseDuring posterior lumbar spinal surgery ,Another group of patients received 1 mg morphine-soaked in epidural oxidized cellulose. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 Yrs
- Good orientation and communication
Key exclusion criteria (9 listed)
- opioids or sulfonamides allergy
- Contraindication for use
- Epidural morphine
- Selective COX 2 inhibitor
- Patient-controlled analgesia (PCA)
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 |
|---|---|---|
| 1 mg morphine soak in epidural oxidized celluloseDuring posterior lumbar spinal surgery , patients received 1 mg morphine-soaked in epidural oxidized cellulose. | Drug | 1 mg morphine soak in epidural oxidized cellulose |
| normal salineDuring posterior lumbar spinal surgery , patients received NSS -soaked in epidural oxidized cellulose. | Drug | normal saline |
Primary outcome
VAS measurement was recorded at twenty-four hour after posterior lumbar spinal surgery then compare VAS between low-dose 1 mg morphine-soaked microfibrillar collagen sponge method with normal saline soked
Time frame: 2 years
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 20 Feb 2014.
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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 1 mg morphine soak in epidural oxidized cellulose and normal saline in people with Morphine, 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 2 inclusion and 9 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 20 Feb 2014. 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?
VAS measurement was recorded at twenty-four hour after posterior lumbar spinal surgery then compare VAS between low-dose 1 mg morphine-soaked microfibrillar collagen sponge method with normal saline soked (time frame: 2 years). 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 20 Feb 2014.