Acute Pain Following Decompressive Lumbar Spinal SurgeryPhase 4ITMPNCT01053039
The Use of Intrathecal Morphine in the Management of Acute Pain Following Decompressive Lumbar Spinal Surgery
A Phase 4 study testing Intrathecal Morphine and Intrathecal Saline in people with Acute Pain Following Decompressive Lumbar Spinal Surgery, run by University of Calgary at 1 site in Canada.
Trial summary
The primary aim of this study is to assess the impact of intrathecal morphine on post-operative pain following instrumented fusion for degenerative lumbar spine disease. Secondary objectives of this study aim to assess side effects, overall narcotic use and duration of hospital stay following administration of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Pain Following Decompressive Lumbar Spinal Surgery
- What is being tested?
- Intrathecal Morphine and Intrathecal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to Feb 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age 18yrs or older
- elective surgery for instrumented fusion of the lumbar spine for stenosis (< 5 levels)
- with back and/or leg pain
- patients who meet ASA class 1 or 2
Who cannot join
- Patients unable to speak english
- known allergies to morphine or other opioids
- spinal surgery other than lumbar spine surgery
- history of severe respiratory illness including COPD and asthma
- history of obstructive sleep apnea
- pregnancy
Show all 11Show fewer
- lumbar procedures performed in minimally invasive fashion
- patients lacking mental capacity to use PCA
- patients on sustained release narcotics
- patients undergoing revision of previous instrumented lumbar spine surgery
- patients with psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Intrathecal Morphine in the Management of Acute Pain Following Decompressive Lumbar Spinal Surgery: A Randomized Controlled Trial
The primary aim of this study is to assess the impact of intrathecal morphine on post-operative pain following instrumented fusion for degenerative lumbar spine disease. Secondary objectives of this study aim to assess side effects, overall narcotic use and duration of hospital stay following administration of intrathecal morphine.
Based on our literature review, we expect a significant improvement in pain scores and functional status and minimal side effects with the use of intrathecal morphine. With improved pain and function we would also expect shorter hospital stays in those patients receiving intrathecal morphine.
Read the detailed description
Adult patients (>18 yrs or older) undergoing instrumented fusion for degenerative lumbar spine disease will be recruited and randomized to receive one of two treatments. The first group will receive an injection of morphine (200mcg) into the intrathecal space at the time of the operation. The second group will receive a saline injection. The pharmacy will prepare the aforementioned injections and deliver them to the operating room to ensure all parties are blinded. Both groups will then have a standardized analgesic regimen (including PCA morphine and parenteral analgesics) available to them in the post-operative period. Each group will be followed at regular intervals post-operatively. At each follow-up, visual analogue pain scores, side effects and narcotic use will be assessed. Patients will also have a daily functional assessment which will dictate the time of discharge. Hospital stay will be measured from time of admission to time where patient no longer requires acute hospital care based on the functional assessment.
- Being tested
- Intrathecal Morphine, Intrathecal Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal MorphineDrug
Also called Epimorph
Treatment group to receive 0.2mg of intrathecal morphine followed by PCA morphine.
Intrathecal SalineDrug
The control group will receive intrathecal saline followed by PCA. All patients will receive a standardized postoperative regimen.
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal Morphine | Active comparator | Treatment group to receive 0.2mg of intrathecal morphine followed by PCA morphine. Receives: Drug: Intrathecal Morphine |
| Intrathecal Saline | Placebo comparator | The control group will receive intrathecal saline followed by PCA. All patients will receive a standardized postoperative regimen. Receives: Drug: Intrathecal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary aim of this study is to assess the impact of intrathecal morphine on post-operative pain following instrumented fusion for lumbar spinal stenosis.
Measured: Pre-op to discharge
Secondary outcomes (1)
Secondary objectives of this study aim to assess side effects, overall narcotic use and duration of hospital stay following administration of intrathecal morphine.
Measured: Pre-op to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionNov 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pain Following Decompressive Lumbar Spinal SurgeryStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Stephan du Plessis, University of Calgary
- Investigators
- Stephan J du Plessis, MD, FRCSC, Principal investigator, Chairman, University of Calgary Spine Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053039
- Sponsor's protocol ID
- 22518
- Acronym
- ITMP
- Status last verified
- Dec 2015
- First submitted
- 19 Jan 2010
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Intrathecal Morphine in the Management of Acute Pain Following Decompressive Lumbar Spinal Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01053039
- Acronym / sponsor ID
- ITMP / 22518
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Nov 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 21 Jan 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 primary aim of this study is to assess the impact of intrathecal morphine on post-operative pain following instrumented fusion for degenerative lumbar spine disease. Secondary objectives of this study aim to assess side effects, overall narcotic use and duration of hospital stay following administration of intrathecal morphine.
Based on our literature review, we expect a significant improvement in pain scores and functional status and minimal side effects with the use of intrathecal morphine. With improved pain and function we would also expect shorter hospital stays in those patients receiving intrathecal morphine.
Detailed description
Adult patients (>18 yrs or older) undergoing instrumented fusion for degenerative lumbar spine disease will be recruited and randomized to receive one of two treatments. The first group will receive an injection of morphine (200mcg) into the intrathecal space at the time of the operation. The second group will receive a saline injection. The pharmacy will prepare the aforementioned injections and deliver them to the operating room to ensure all parties are blinded. Both groups will then have a standardized analgesic regimen (including PCA morphine and parenteral analgesics) available to them in the post-operative period. Each group will be followed at regular intervals post-operatively. At each follow-up, visual analogue pain scores, side effects and narcotic use will be assessed. Patients will also have a daily functional assessment which will dictate the time of discharge. Hospital stay will be measured from time of admission to time where patient no longer requires acute hospital care based on the functional assessment.
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 |
|---|---|---|
| Intrathecal Morphine | Active comparator | Drug: Intrathecal MorphineTreatment group to receive 0.2mg of intrathecal morphine followed by PCA morphine. |
| Intrathecal Saline | Placebo comparator | Drug: Intrathecal SalineThe control group will receive intrathecal saline followed by PCA. All patients will receive a standardized postoperative regimen. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- age 18yrs or older
- elective surgery for instrumented fusion of the lumbar spine for stenosis (< 5 levels)
- with back and/or leg pain
- patients who meet ASA class 1 or 2
Key exclusion criteria (11 listed)
- Patients unable to speak english
- known allergies to morphine or other opioids
- spinal surgery other than lumbar spine surgery
- history of severe respiratory illness including COPD and asthma
- history of obstructive sleep apnea
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 |
|---|---|---|
| Intrathecal MorphineAlso: EpimorphTreatment group to receive 0.2mg of intrathecal morphine followed by PCA morphine. | Drug | Intrathecal Morphine |
| Intrathecal SalineThe control group will receive intrathecal saline followed by PCA. All patients will receive a standardized postoperative regimen. | Drug | Intrathecal Saline |
Primary outcome
The primary aim of this study is to assess the impact of intrathecal morphine on post-operative pain following instrumented fusion for lumbar spinal stenosis.
Time frame: Pre-op to discharge
1 secondary outcome
Secondary objectives of this study aim to assess side effects, overall narcotic use and duration of hospital stay following administration of intrathecal morphine.
Time frame: Pre-op to discharge
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 Dec 2015.
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.
Stephan J du Plessis, MD, FRCSC principal investigator
Chairman, University of Calgary Spine Program
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 Intrathecal Morphine and Intrathecal Saline in people with Acute Pain Following Decompressive Lumbar Spinal Surgery, run by University of Calgary at 1 site in Canada.
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 11 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 Dec 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 Canada. 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?
The primary aim of this study is to assess the impact of intrathecal morphine on post-operative pain following instrumented fusion for lumbar spinal stenosis. (time frame: Pre-op to discharge). 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 16 Dec 2015.