RECRUITING

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Randomized, Placebo-controlled Trial of Erector Spinae Plane Blocks (ESPB) for Perioperative Pain Management for Minimally Invasive (MIS) Lumbar Spine Surgery

Quick Facts

Study Start:2022-02-01
Study Completion:2025-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05029726

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-80
  2. * 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
  3. * Willing and able to give consent
  1. * 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)
  2. * Presence of an indwelling pain device (e.g., intrathecal opioid pump, spinal cord stimulator, dorsal root ganglion stimulator)
  3. * Known allergy to bupivacaine, clonidine or similar local anesthetics
  4. * Indication for surgery other than degenerative disease (e.g., neoplasm, infection, trauma)
  5. * Chronic kidney disease (stage 3 or greater), or hepatic failure
  6. * Active pregnancy
  7. * Disease process or mental illness that would preclude accurate evaluation of pain in the perioperative period
  8. * Active Worker's Compensation litigation

Contacts and Locations

Study Contact

Bart Jacher
CONTACT
(888) 352-7874
bartosz_jacher@rush.edu
Morgan Mulcahy
CONTACT
(888) 352-7874
morgan_l_mulcahy@rush.edu

Principal Investigator

John O'Toole, MD
PRINCIPAL_INVESTIGATOR
Rush University Medical Center

Study Locations (Sites)

Rush University Medical Center
Chicago, Illinois, 60612
United States

Collaborators and Investigators

Sponsor: John O'Toole

  • John O'Toole, MD, PRINCIPAL_INVESTIGATOR, Rush University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-01
Study Completion Date2025-04-30

Study Record Updates

Study Start Date2022-02-01
Study Completion Date2025-04-30

Terms related to this study

Keywords Provided by Researchers

  • erector spinae plane block
  • minimally invasive spine surgery
  • regional anesthesia
  • randomized controlled trial

Additional Relevant MeSH Terms

  • Lumbar Spinal Stenosis
  • Lumbar Disc Herniation
  • Lumbar Spondylolisthesis
  • Lumbar Spondylosis
  • Lumbar Radiculopathy
  • Lumbar Spine Instability
  • Synovial Cyst
  • Degenerative Disc Disease
  • Degenerative Spondylolisthesis
  • Degenerative Intervertebral Discs