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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Patient receives standard of care anesthesia with TLIP Block of bupivicaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
Blood Tests measuring inflammatory markers: IL-10, MCP-1, IL-8, IL-6, TNFa
Questionnaire that will rate each symptom of delirium
Questionnaire for screening and severity measurement of generalized anxiety disorder.
Questionnaire assessing pain intensity
Questionnaire measuring the effect of pain on patient physical, emotional, and social functioning.
Questionnaire assessing disability and quality of life impairment in adults with lower back pain.
Questionnaire assessing baseline cognition.
16 item clinician rated scale assessing delirium severity.
Telephone interview questionnaire evaluating patient cognitive status.
The amount of opioids administered will be collected through patient self-report
Questionnaire used to diagnose and determine the severity measure for depressive disorders.
Scale used to determine pain catastrophizing and it's severity.
Questionnaire used to help predict patients that have a high pain avoidance behavior.
Survey determining adverse events related to opioid side effects and complications.
Questionnaire assessing pain location, severity, impact to quality of life, and medications used to alleviate.
Questionnaire assessing Kinesiophobia
Questionnaire assessing postoperative quality of recovery
University of Iowa
Iowa City, Iowa, United States
RECRUITINGNumerical Rating Score
Change in pain will be assessed using the Numerical Rating Score Questionnaire immediately before surgery and at 2, 6 and 12 weeks post-operatively.
Time frame: Change assessed from pre-surgery to 12 weeks post-operatively.
Daily Pain Trajectory
Change in pain will be assessed using the Daily Pain Trajectory survey each day post-operatively for 30 days.
Time frame: Change assessed from 1 day to 30 days post-operatively
Pain Catastrophizing
Change in pain catastrophizing and severity will be assessed using the Pain Catastrophizing scale immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Time frame: Change from Pre-operation score to 12 weeks post-operatively
Pain Fear and Avoidance
Change in pain fear and subject avoidance will be assessed using the Pain Fear and Avoidance Questionnaire immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Time frame: Change from Pre-operation score to 12 weeks post-operatively
Pain Interference
Change in how pain interferes with patient physical, emotional, and social functioning will be assessed using the PROMIS - Pain Interference questionnaire immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Time frame: Change from Pre-operation score to 12 weeks post-operatively
Generalized Anxiety Disorder
Change in severity measurement of generalized anxiety disorder assessed using the Generalized Anxiety Disorder 7 item scale immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Time frame: Change from pre-operation score to 12 weeks post-operatively
Personal Health Questionnaire Depression Scale
Change in depression will be assessed using the Personal Health Questionnaire Depression Scale measured immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Time frame: Change from pre-operation score to 12 weeks post-operatively
Oswestry disability index
Change in disability score will be assessed using the Oswestry disability index measured immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Time frame: Change from Pre-operative score to 12 weeks post-operatively
Tampa Scale of Kinesiophobia
Change in kinesiophobia will be assessed using the Tampa Scale of Kinesiophobia measured immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Time frame: Change from Pre-operative score to 12 weeks post-operatively
Delirium Rating Scale-Revised-98
Change in delirium severity will be assessed using the Delirium Rating Scale-Revised-98 16 item clinician rated scale measured immediately before surgery and at 1 day, 2 days, 3 days, 2 weeks, 6 weeks, and 12 weeks post-operatively.
Time frame: Change from Pre-operative score to 12 weeks post-operatively
3D-CAM-S and 3D-CAM-ICU
Change in delirium symptoms will be assessed using the 3D-CAM-S and 3D-CAM-ICU Questionnaire measured immediately before surgery and at 1 day, 2 days, 3 days, 2 weeks, 6 weeks, and 12 weeks post-operatively.
Time frame: Change from Pre-operative score to 12 weeks post-operatively
Modified Telephone Interview of Cognitive Status
Change in cognitive status will be assessed using the Modified Telephone Interview of cognitive Status measured immediately before surgery and at 6, and 12 weeks post-operatively.
Time frame: Change from Pre-operative score to 12 weeks post-operatively
Saint Louis University Mental Status Examination (SLUMs)
Change in baseline cognition will be assessed using the Saint Louis University Mental Status Examination measured immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Time frame: Change from Pre-operative score to 12 weeks post-operatively.
Opioid Use
Opioid use will be calculated pre- and post-operatively using the Morphine Milligram Equivalents from patient self-reports.
Time frame: Change from pre-operative score through 12 weeks post-operatively
Opioid Side Effects and Likability Questionnaire
Change in adverse events related to opioid side effects and complications will be assessed using the Opioid Side Effects and Likeability Questionnaire measured 1 week and 4 weeks post-operatively.
Time frame: Change from 1 week post-operative results to 4 weeks post-operation.
Self-reported Adverse Events
Change in adverse events related to opioid use and post-surgical outcomes will be collected post-operatively through the electronic health record from patient self-report. This will be measured immediately before surgery and 1, 2, 4, 6, and 12 weeks post-operatively
Time frame: Change from pre-operative result through 12 weeks post-operatively.
Length of Hospitalization
The length of time patients were hospitalized will be collected through the electronic health record.
Time frame: Through study completion, 16 months
Disposition to skilled-facilities
Where patients are dispositioned post-operatively will be collected through the electronic health record.
Time frame: Through study completion, 16 months
90-day Readmission Rates
The 90-day readmission rates will be collected through the electronic health record.
Time frame: Through study completion, 16 months
Blood test for Inflammation
Blood test for IL-10, MCP-1, NfL, IL-6, and IL-8 will be done pre- and post-surgery for presence and levels of IL-10, MCP-1, NfL, IL-6, and IL-8.
Time frame: Measured Immediately before surgery and 1 day post-operatively
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