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RecruitingPhase 4NCT05029726

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

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Trial Parameters

ConditionLumbar Spinal Stenosis
SponsorJohn O'Toole
Study TypeINTERVENTIONAL
PhasePhase 4
Enrollment125
SexALL
Min Age18 Years
Max Age80 Years
Start Date2022-02-01
Completion2027-02-01
Interventions
Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidinenormal saline

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Brief 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 Criteria

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

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