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Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

RECRUITINGPhase 4Sponsored by John O'Toole
Actively Recruiting
PhasePhase 4
SponsorJohn O'Toole
Started2022-02-01
Est. completion2027-02-01
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years – 80 YearsHealthy volunteers accepted
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

Conditions11

CancerDegenerative Disc DiseaseDegenerative Intervertebral DiscsDegenerative SpondylolisthesisLumbar Disc HerniationLumbar RadiculopathyLumbar Spinal StenosisLumbar Spine InstabilityLumbar SpondylolisthesisLumbar Spondylosis

Locations1 site

Rush University Medical Center
Bart Jacher888-352-7874bartosz_jacher@rush.edu

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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