Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
University of Iowa
Study ID
NCT05461092
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Delirium
  • Pain, Back
  • Spinal Fusion
  • Thoracolumbar Interfascial Plane Block

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine — DRUG
    Patient receives standard of care anesthesia with TLIP Block of bupivicaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
  • Blood Test — DIAGNOSTIC_TEST
    Blood Tests measuring inflammatory markers: IL-10, MCP-1, IL-8, IL-6, TNFa
  • 3D CAM Delirium Severity Scoring — OTHER
    Questionnaire that will rate each symptom of delirium
  • Generalized Anxiety Disorder 7-item (GAD-7) scale — OTHER
    Questionnaire for screening and severity measurement of generalized anxiety disorder.
  • Numerical Rating Score (NRS) — OTHER
    Questionnaire assessing pain intensity
  • PROMIS-Pain Interference — OTHER
    Questionnaire measuring the effect of pain on patient physical, emotional, and social functioning.
  • Oswestry Disability Index (ODI) — OTHER
    Questionnaire assessing disability and quality of life impairment in adults with lower back pain.
  • Saint Louis University Mental Status Examination (SLUMs) — OTHER
    Questionnaire assessing baseline cognition.
  • Delirium Rating Scale-Revised-98 (DRS) — OTHER
    16 item clinician rated scale assessing delirium severity.
  • Telephone Interview for Cognitive Status - Modified (TICS-M) — OTHER
    Telephone interview questionnaire evaluating patient cognitive status.
  • Opioid Equivalents measured by Morphine Milligram Equivalents (MME) — OTHER
    The amount of opioids administered will be collected through patient self-report
  • Patient Health Questionnaire depression scale (PHQ-8) — OTHER
    Questionnaire used to diagnose and determine the severity measure for depressive disorders.
  • Pain Catastrophizing — OTHER
    Scale used to determine pain catastrophizing and it's severity.
  • Fear Avoidance Beliefs Questionnaire (FABQ) — OTHER
    Questionnaire used to help predict patients that have a high pain avoidance behavior.
  • Opioid Side Effects and Likeability Questionnaire — OTHER
    Survey determining adverse events related to opioid side effects and complications.
  • Daily Pain Trajectory — OTHER
    Questionnaire assessing pain location, severity, impact to quality of life, and medications used to alleviate.
  • Tampa Scale of Kinesiophobia — OTHER
    Questionnaire assessing Kinesiophobia
  • Quality of Recovery 15 — OTHER
    Questionnaire assessing postoperative quality of recovery

Study Details

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 Dates

Start date
Jan 1, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
    Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
  • Experimental: Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
    Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.

Primary Outcome Measure

Numerical Rating Score [ Time Frame: Change assessed from pre-surgery to 12 weeks post-operatively. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52242-

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By research site
University of Iowa· Iowa City, IA

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