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
Sponsors and collaborators
John O'Toole
Lead sponsor
Rush University Medical Center
Sponsor institution