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Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion
Sponsor: University of Iowa
Summary
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.
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2024-01-01
Completion Date
2026-12-31
Last Updated
2026-03-27
Healthy Volunteers
No
Interventions
Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
Patient receives standard of care anesthesia with TLIP Block of bupivicaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
Blood Test
Blood Tests measuring inflammatory markers: IL-10, MCP-1, IL-8, IL-6, TNFa
3D CAM Delirium Severity Scoring
Questionnaire that will rate each symptom of delirium
Generalized Anxiety Disorder 7-item (GAD-7) scale
Questionnaire for screening and severity measurement of generalized anxiety disorder.
Numerical Rating Score (NRS)
Questionnaire assessing pain intensity
PROMIS-Pain Interference
Questionnaire measuring the effect of pain on patient physical, emotional, and social functioning.
Oswestry Disability Index (ODI)
Questionnaire assessing disability and quality of life impairment in adults with lower back pain.
Saint Louis University Mental Status Examination (SLUMs)
Questionnaire assessing baseline cognition.
Delirium Rating Scale-Revised-98 (DRS)
16 item clinician rated scale assessing delirium severity.
Telephone Interview for Cognitive Status - Modified (TICS-M)
Telephone interview questionnaire evaluating patient cognitive status.
Opioid Equivalents measured by Morphine Milligram Equivalents (MME)
The amount of opioids administered will be collected through patient self-report
Patient Health Questionnaire depression scale (PHQ-8)
Questionnaire used to diagnose and determine the severity measure for depressive disorders.
Pain Catastrophizing
Scale used to determine pain catastrophizing and it's severity.
Fear Avoidance Beliefs Questionnaire (FABQ)
Questionnaire used to help predict patients that have a high pain avoidance behavior.
Opioid Side Effects and Likeability Questionnaire
Survey determining adverse events related to opioid side effects and complications.
Daily Pain Trajectory
Questionnaire assessing pain location, severity, impact to quality of life, and medications used to alleviate.
Tampa Scale of Kinesiophobia
Questionnaire assessing Kinesiophobia
Quality of Recovery 15
Questionnaire assessing postoperative quality of recovery
Locations (1)
University of Iowa
Iowa City, Iowa, United States