Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

• Status: Not yet recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: John O'Toole
• Treatments: Bupivacaine; Clonidine; Epinephrine

Criteria

Inclusion Criteria:

• Age 18-75

• 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