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Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery
Randomized, Placebo-controlled Trial of Erector Spinae Plane Blocks (ESPB) for Perioperative Pain Management for Minimally Invasive (MIS) Lumbar Spine Surgery
Who can join
Ages 18 to 80 · All sexes
Full 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
About the study
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.
What is being tested
- Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine (drug)
- normal saline (drug)
Sponsor: John O'Toole · Participants: 125 · Started: Feb 1, 2022
Contact the study team
- Bart Jacher · Phone: (888) 352-7874
- Morgan Mulcahy · Phone: (888) 352-7874
Official record on ClinicalTrials.gov — NCT05029726
Locations in the U.S.
| Illinois | Rush University Medical Center, Chicago |
Conditions
- Spinal Stenosis
- Herniated Disk
- Spondylolisthesis
- Spondylosis
- Radiculopathy
- Intervertebral Disc Degeneration
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.