Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJohn O'Toole

About this trial

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

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine
  • normal saline

Treatment groups

125 Participants
are divided into 2 treatment groups

Sponsors and collaborators

John O'Toole

Lead sponsor

Rush University Medical Center

Sponsor institution