NCT05029726 Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery
| NCT ID | NCT05029726 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | John O'Toole |
| Condition | Lumbar Spinal Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 125 participants |
| Start Date | 2022-02-01 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 125 participants in total. It began in 2022-02-01 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Opioid overuse is a widespread public health crisis in the United States with increasing rates of addiction and overdose deaths from prescription opioids. Reducing the need for opiate analgesics in the post-operative setting has become a high priority in minimizing long-term opioid use in surgical patients. This study will serve to demonstrate the efficacy of the addition of regional analgesic techniques in reducing post-operative opioid requirements in patients undergoing common lumbar spinal surgical procedures.
Eligibility Criteria
Inclusion Criteria: * Age 18-80 * Undergoing one of 3 procedure types: 1) 2 or more levels of MIS decompression (e.g., discectomy, foraminotomy, laminectomy); 2) 1-3 levels of MIS transforaminal lumbar interbody fusion (TLIF) (with or without additional levels of MIS decompression for no greater than 3 total operative levels); 3) 1-3 levels of anterior lumbar interbody fusion (ALIF) or MIS lateral lumbar interbody fusion (LLIF) accompanied by posterior percutaneous instrumentation at the same levels * Willing and able to give consent Exclusion Criteria: * Opioid tolerant at the time of the surgical procedure--defined as consuming greater than 30mg of morphine milligram equivalents (MME) daily (https://www.cdc.gov/drugoverdose/prescribing/guideline.html) * Presence of an indwelling pain device (e.g., intrathecal opioid pump, spinal cord stimulator, dorsal root ganglion stimulator) * Known allergy to bupivacaine, clonidine or similar local anesthetics * Indication for surgery other than degenerative disease (e.g., neoplasm, infection, trauma) * Chronic kidney disease (stage 3 or greater), or hepatic failure * Active pregnancy * Disease process or mental illness that would preclude accurate evaluation of pain in the perioperative period * Active Worker's Compensation litigation
Contact & Investigator
John O'Toole, MD
PRINCIPAL INVESTIGATOR
Rush University Medical Center
Frequently Asked Questions
Who can join the NCT05029726 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Lumbar Spinal Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05029726 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05029726 currently recruiting?
Yes, NCT05029726 is actively recruiting participants. Contact the research team at bartosz_jacher@rush.edu for enrollment information.
Where is the NCT05029726 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT05029726 clinical trial?
NCT05029726 is sponsored by John O'Toole. The principal investigator is John O'Toole, MD at Rush University Medical Center. The trial plans to enroll 125 participants.