Thoracolumbar Block for Spinal Fusion Recovery
Trial Summary
What is the purpose of this trial?
This initial study is a feasibility study for implementing thoracolumbar interfascial plane, or TLIP, blocks in older adults undergoing spinal fusion. TLIP blocks are done by using anesthesia. In this case, it will be done to either side of the back where surgery will be performed. This has been shown to decrease pain the patients have post-operatively in previous research. In this study, the investigators will examine recruitment rates, completion of assessments, dropout rate, gather patient feedback, and identify barriers to performing TLIP. Further, this feasibility study will provide data to determine adequate sample size and refine methods and outcomes for a future randomized clinical trial. The ultimate goal is to perform a large, appropriately powered randomized control trial to determine the effect of TLIP blocks on pain, physical function and disability, opioid consumption, and delirium in older adult undergoing spinal fusion.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are opioid tolerant (taking more than 60 mg of morphine equivalent per day), you may not be eligible to participate.
What data supports the effectiveness of the treatment Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine for spinal fusion recovery?
Is the Thoracolumbar Interfascial Plane (TLIP) Block safe for humans?
How does the thoracolumbar block treatment differ from other treatments for spinal fusion recovery?
The thoracolumbar block is a unique treatment for spinal fusion recovery because it is a regional anesthetic technique that specifically targets the dorsal rami of spinal nerves to provide pain relief. This minimally invasive approach can reduce the need for opioids and enhance recovery, making it different from traditional pain management methods that often rely heavily on systemic medications.12345
Research Team
Catherine R Olinger, MD
Principal Investigator
Clinical Assistant Professor
Eligibility Criteria
This trial is for adults aged 65 or older who need lumbar spinal fusion surgery of up to three levels and have no severe heart, lung diseases, cognitive dysfunction, or allergies to local anesthetics. It's not for those with major liver/kidney issues, opioid tolerance, other chronic pain conditions, significant neurological deficits, psychiatric illnesses, under age 65, pregnant/breastfeeding women or those with a high BMI.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive standard of care anesthesia with or without TLIP Block of bupivacaine during spinal fusion surgery
Post-operative Monitoring
Participants are monitored for changes in pain, opioid use, and other health outcomes immediately after surgery and at various intervals up to 12 weeks post-operatively
Follow-up
Participants are monitored for safety and effectiveness after treatment, including 90-day readmission rates and disposition to skilled facilities
Treatment Details
Interventions
- Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine (Local Anesthetic)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Iowa
Lead Sponsor