Intrathecal Morphine vs Intrathecal Morphine Combined With Clonidine for 1-2 Level Lumbar Fusion
| Registry | NCT07846657 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 70 (Estimated) |
| Sponsor | MaineHealth (Other) |
| Conditions | Lumbar Fusion Surgery |
| Interventions | Intrathecal Morphine + Intrathecal Clonidine, Intrathecal Morphine (Drug) |
| Dates | start 2026-10-01 (estimated), primary completion 2027-12-31 (estimated), completion 2028-01-30 (estimated), first posted 2026-09-29, last updated 2026-10-05 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Lumbar Fusion Surgery All trials of Intrathecal Morphine + Intrathecal Clonidine All trials of Intrathecal Morphine
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intrathecal Morphine | Active comparator | Drug: Intrathecal Morphine | Participants in this group will receive the current standard of care. |
| Intrathecal Morphine + Intrathecal Clonidine | Experimental | Drug: Intrathecal Morphine + Intrathecal Clonidine | Participants in this group will receive the experimental treatment; the standard of care with the addition of 75 mcg of intrathecal clonidine. |
Sex: All, ages: 18 Years to 70 Years
Inclusion Criteria: * 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 Exclusion Criteria: * 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) * 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
| Facility | City | Country | Status |
|---|---|---|---|
| MaineHealth Maine Medical Center-Portland | Portland, Maine | United States |