Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

This study is looking at ways to reduce the need for opioid pain medications after minimally invasive lumbar (lower back) spine surgery. Researchers are comparing two different injections given during surgery: one containing Bupivacaine-Epinephrine 0.25%-1:200,000 plus clonidine, and another containing normal saline (salt water). Both injections are given using a technique called ESPB. The goal is to see if the Bupivacaine-Epinephrine injection can help patients use less opioid pain medication after surgery. You may be able to join if you are between 18 and 80 years old and are having certain types of minimally invasive lumbar spine surgery for conditions like lumbar spinal stenosis or disc herniation. The study is currently unclear on its recruitment status.

Study design
This is an interventional study with a planned enrollment of 125 participants. It compares two different drug interventions.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your opioid consumption will be measured every day during your inpatient admission, for up to 30 days.

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NCT05029726

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

Recruiting
PHASE4Ages 18–80InterventionalTreatment
John O'Toole
~125 participants
Updated 2026-02-17 on ClinicalTrials.gov
What's tested:Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidinenormal saline

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Inpatient opioid consumption
Measured over Every 1 day during inpatient admission up to 30 days
Lumbar Spinal Stenosis
Lumbar Disc Herniation
Lumbar Spondylolisthesis
Lumbar Spondylosis
Lumbar Radiculopathy
Lumbar Spine Instability
Synovial Cyst
Degenerative Disc Disease
Degenerative Spondylolisthesis
Degenerative Intervertebral Discs
1 sites across 1 states
Illinois1
  • John O'Toole, MD · PRINCIPAL_INVESTIGATOR · Rush University Medical Center

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Eligibility criteria

Inclusion

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

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
  • Inpatient opioid consumptionEvery 1 day during inpatient admission up to 30 days

    Mean per day inpatient opioid consumption in morphine milligram equivalents (MME)