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
John O'Toole
125 participants
Feb 1, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria8
- 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
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Interventions
Bupivacaine-Epinephrine 0.25%-1:200,000 plus clonidine 50 micrograms in 30cc syringes administered as ESPB
normal saline in 30cc syringes administered using ESPB technique
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05029726