Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion
University of Iowa
50 participants
Jan 1, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- Are 65 or older
- Indicated for lumbar spinal fusion of less than or equal to 3 levels
- Undergoing elective surgery
- no contraindications to local anesthetic or procedures
- no severe cardiac or respiratory disease
- no preexisting cognitive dysfunction/dementia
Exclusion Criteria16
- years old and younger
- emergency treatment
- pathologic fractures
- seeking revision surgery
- major liver or kidney dysfunction
- coexisting hematological disorder or irreversible abnormal coagulation
- patients with previous diagnosis of dementia or SLUMS score \<20
- patient unable to communicate/cooperate/language barrier
- BMI\>40
- allergy to study medications
- opioid tolerant (oral opioid intake morphine equivalent =\< 60 mg/day)
- other sources of chronic pain like fibromyalgia
- patients with associated significant CNS or respiratory disease (home oxygen requirements)
- incarcerated patients
- psychiatric illnesses preoperative neurological deficits greater than one motor group, less than three out of five motor functions
- pregnant or breast feeding
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Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05461092