NCT05029726 · John O'Toole
Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine
Bupivacaine-Epinephrine 0.25%-1:200,000 plus clonidine 50 micrograms in 30cc syringes administered as ESPB
DRUG
normal saline
normal saline in 30cc syringes administered using ESPB technique
Primary outcome measures
Inpatient opioid consumption
Time frame: Every 1 day during inpatient admission up to 30 days
Mean per day inpatient opioid consumption in morphine milligram equivalents (MME)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 17, 2026 · Source of record for eligibility and locations