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Search / Trial NCT05029726

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

Launched by JOHN O'TOOLE · Aug 25, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Erector Spinae Plane Block Minimally Invasive Spine Surgery Regional Anesthesia Randomized Controlled Trial

ClinConnect Summary

This clinical trial is studying how using regional anesthesia (a type of pain relief that numbs a specific area) can help reduce the amount of opioids needed after certain surgeries on the lower back. The goal is to find ways to manage pain effectively while lowering the risk of opioid addiction, which has become a serious issue in the United States. Participants in the study will be patients aged 18 to 80 who are scheduled to undergo specific types of minimally invasive spine surgeries, such as decompression or fusion procedures.

To join the trial, participants must not be using high doses of opioids before their surgery and must be able to provide consent. Those who have allergies to certain medications, are pregnant, or have specific health conditions may not be eligible. If you decide to participate, you can expect to receive care that focuses on pain management with regional anesthesia, helping you recover with less reliance on prescription opioids. This study is currently recruiting participants, so it could be an important opportunity for those needing spinal surgery.

Gender

ALL

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 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

About John O'toole

John O'Toole is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative studies. With a strong emphasis on collaboration and ethical practices, John O'Toole engages with healthcare professionals and research institutions to facilitate rigorous clinical trials across various therapeutic areas. By leveraging cutting-edge methodologies and a patient-centric approach, the organization aims to accelerate the development of new treatments while ensuring the highest standards of safety and efficacy.

Locations

Chicago, Illinois, United States

Patients applied

0 patients applied

Trial Officials

John O'Toole, MD

Principal Investigator

Rush University Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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