Lumbar Fusion SurgeryPhase 3NCT07846657
ITM vs ITM+Clonidine for Lumbar Fusions
A Phase 3 study testing Intrathecal Morphine + Intrathecal Clonidine and Intrathecal Morphine in people with Lumbar Fusion Surgery, run by MaineHealth at 1 site in United States.
Trial summary
Dr. Parker Merrill (anesthesiologist) and Dr. Chris Neal (neurosurgeon) are working on a research study comparing two methods of pain control for patients having spinal fusion surgery. We are looking for English-speaking patients between 18 and 70 years old who are scheduled for 1-2 level lumbar spine fusion surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lumbar Fusion Surgery
- What is being tested?
- Intrathecal Morphine + Intrathecal Clonidine and Intrathecal Morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 30 Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- 18-70 years of age
- Scheduled for 1-2 level lumbar fusion
- Expected post-operative inpatient stay of at least 24 hours
- ASA I-III
- English speaking
Who cannot join
- Substance use disorder
- Chronic pain (opioid use of 90 MME daily prior to surgery)
- BMI > 40
- Allergies to clonidine or morphine
- Emergent surgery
- Coagulopathy (INR >1.5)
Show all 14Show fewer
- Platelet count <80
- Significant cardiovascular disease
- baseline systolic blood pressure <100
- Patients on clonidine prior to surgery
- Patients scheduled for a revision surgical procedure
- Patients who are unable to give informed consent
- Pregnant patients
- Prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
MaineHealth Maine Medical Center-Portland
Portland, Maine, 04102
Janelle Research Coordinator, 207-662-2862, janelle.richard@mainehealth.org
About this study
Official title: Intrathecal Morphine vs Intrathecal Morphine Combined With Clonidine for 1-2 Level Lumbar Fusion
Dr. Parker Merrill (anesthesiologist) and Dr. Chris Neal (neurosurgeon) are working on a research study comparing two methods of pain control for patients having spinal fusion surgery.
We are looking for English-speaking patients between 18 and 70 years old who are scheduled for 1-2 level lumbar spine fusion surgery.
Read more
Participants in this study will either get morphine injected during surgery (current pain treatment) or morphine and another drug, clonidine. There is an equal chance of getting the two treatment options. No matter which group you are assigned to, you will be provided with additional pain medication if needed after your surgery.
You may not directly benefit from participating in this study, but you might have an improvement in your pain after surgery. You will also be helping researchers and doctors find better pain control options for future patients.
Read the detailed description
The purpose of this study is to try to improve the medications we give to patients to help with their pain after surgery. Many positive changes have been made over the years, but there remains room for improvement. Lumbar spine surgery allows for easy access to the intrathecal space (the fluid around the spinal cord, or CSF) where medications can be given to directly work on pain receptors in the spinal cord. We know that two medications, morphine and clonidine, can be helpful for pain relief when given into the CSF. Our hypothesis is that adding clonidine and morphine together may offer better pain control than just morphine alone. We hope this study will give us more pain-control options for patients having spine surgery.
- Conditions
- Lumbar Fusion Surgery
- Being tested
- Intrathecal Morphine + Intrathecal Clonidine, Intrathecal Morphine
- Keywords
- lumbar fusion, intrathecal morphine, intrathecal clonidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal Morphine + Intrathecal ClonidineDrug
Participants in the intervention group will receive the standard of care (150 mcg of intrathecal morphine) with the addition of 75 mcg of clonidine.
Intrathecal MorphineDrug
Participants in this group will receive the standard of care; 150 mcg of intrathecal morphine
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal Morphine | Active comparator | Participants in this group will receive the current standard of care. Receives: Drug: Intrathecal Morphine |
| Intrathecal Morphine + Intrathecal Clonidine | Experimental | Participants in this group will receive the experimental treatment; the standard of care with the addition of 75 mcg of intrathecal clonidine. Receives: Drug: Intrathecal Morphine + Intrathecal Clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative opioid consumption
Post-operative opioid consumption measured as morphine milligram equivalents (MME)
Measured: 24 hours post-op
Secondary outcomes (2)
Pain scores
Pain levels as measured using the numeric rating scale (NRS) of 0-10
Measured: 72 hours post-op
Post-operative opioid consumption
Post-operative opioid consumption measured as morphine milligram equivalents (MME)
Measured: 72 hours post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Fusion 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MaineHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Parker Merill, MaineHealth
- Investigators
- Parker Merrill, MD, Principal investigator, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846657
- Sponsor's protocol ID
- STUDY00000209
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified IPD relating to primary and secondary outcomes will be made available following IRB approval and execution of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Morphine vs Intrathecal Morphine Combined With Clonidine for 1-2 Level Lumbar Fusion
- ClinicalTrials.gov ID
- NCT07846657
- Acronym / sponsor ID
- STUDY00000209
- Conditions
- Lumbar Fusion Surgery
- Keywords
- lumbar fusion, intrathecal morphine, intrathecal clonidine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- MaineHealthUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 29 Sep 2026 (actual)
- 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.
Dr. Parker Merrill (anesthesiologist) and Dr. Chris Neal (neurosurgeon) are working on a research study comparing two methods of pain control for patients having spinal fusion surgery.
We are looking for English-speaking patients between 18 and 70 years old who are scheduled for 1-2 level lumbar spine fusion surgery.
Participants in this study will either get morphine injected during surgery (current pain treatment) or morphine and another drug, clonidine. There is an equal chance of getting the two treatment options. No matter which group you are assigned to, you will be provided with additional pain medication if needed after your surgery.
You may not directly benefit from participating in this study, but you might have an improvement in your pain after surgery. You will also be helping researchers and doctors find better pain control options for future patients.
Detailed description
The purpose of this study is to try to improve the medications we give to patients to help with their pain after surgery. Many positive changes have been made over the years, but there remains room for improvement. Lumbar spine surgery allows for easy access to the intrathecal space (the fluid around the spinal cord, or CSF) where medications can be given to directly work on pain receptors in the spinal cord. We know that two medications, morphine and clonidine, can be helpful for pain relief when given into the CSF. Our hypothesis is that adding clonidine and morphine together may offer better pain control than just morphine alone. We hope this study will give us more pain-control options for patients having spine surgery.
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 MorphineParticipants in this group will receive the current standard of care. |
| Intrathecal Morphine + Intrathecal Clonidine | Experimental | Drug: Intrathecal Morphine + Intrathecal ClonidineParticipants in this group will receive the experimental treatment; the standard of care with the addition of 75 mcg of intrathecal clonidine. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-70 years of age
- Scheduled for 1-2 level lumbar fusion
- Expected post-operative inpatient stay of at least 24 hours
- ASA I-III
- English speaking
Key exclusion criteria (14 listed)
- Substance use disorder
- Chronic pain (opioid use of 90 MME daily prior to surgery)
- BMI > 40
- Allergies to clonidine or morphine
- Emergent surgery
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 Morphine + Intrathecal ClonidineParticipants in the intervention group will receive the standard of care (150 mcg of intrathecal morphine) with the addition of 75 mcg of clonidine. | Drug | Intrathecal Morphine + Intrathecal Clonidine |
| Intrathecal MorphineParticipants in this group will receive the standard of care; 150 mcg of intrathecal morphine | Drug | Intrathecal Morphine |
Primary outcome
Post-operative opioid consumption
Time frame: 24 hours post-op
Post-operative opioid consumption measured as morphine milligram equivalents (MME)
2 secondary outcomes
Pain scores
Time frame: 72 hours post-op
Post-operative opioid consumption
Time frame: 72 hours post-op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Yes. Deidentified IPD relating to primary and secondary outcomes will be made available following IRB approval and execution of a data sharing agreement.
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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.
Parker Merrill, MD principal investigator
MaineHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intrathecal Morphine + Intrathecal Clonidine and Intrathecal Morphine in people with Lumbar Fusion Surgery, run by MaineHealth at 1 site in United States.
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 5 inclusion and 14 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: opening soon, as of the sponsor's last update on 5 Oct 2026. 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janelle Research Coordinator (207-662-2862, janelle.richard@mainehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative opioid consumption (time frame: 24 hours post-op). 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 5 Oct 2026.