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NCT Number: NCT05461092

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

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.

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Key information

Conditions

Delirium Back Pain Confusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pain Pain, Back Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Fusion Thoracolumbar Interfascial Plane Block

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 64 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

Treatment and study plan

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

Primary outcomes

  1. Numerical Rating Score

    Time frame: Change assessed from pre-surgery to 12 weeks post-operatively.

    Change in pain will be assessed using the Numerical Rating Score Questionnaire immediately before surgery and at 2, 6 and 12 weeks post-operatively.

  2. Daily Pain Trajectory

    Time frame: Change assessed from 1 day to 30 days post-operatively

    Change in pain will be assessed using the Daily Pain Trajectory survey each day post-operatively for 30 days.

  3. Pain Catastrophizing

    Time frame: Change from Pre-operation score to 12 weeks post-operatively

    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.

  4. Pain Fear and Avoidance

    Time frame: Change from Pre-operation score to 12 weeks post-operatively

    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.

  5. Pain Interference

    Time frame: Change from Pre-operation score to 12 weeks post-operatively

    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.

  6. Generalized Anxiety Disorder

    Time frame: Change from pre-operation score to 12 weeks post-operatively

    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.

  7. Personal Health Questionnaire Depression Scale

    Time frame: Change from pre-operation score to 12 weeks post-operatively

    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.

  8. Oswestry disability index

    Time frame: Change from Pre-operative score to 12 weeks post-operatively

    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.

  9. Tampa Scale of Kinesiophobia

    Time frame: Change from Pre-operative score to 12 weeks post-operatively

    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.

  10. Delirium Rating Scale-Revised-98

    Time frame: Change from Pre-operative score to 12 weeks post-operatively

    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.

  11. 3D-CAM-S and 3D-CAM-ICU

    Time frame: Change from Pre-operative score to 12 weeks post-operatively

    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.

  12. Modified Telephone Interview of Cognitive Status

    Time frame: Change from Pre-operative score to 12 weeks post-operatively

    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.

  13. Saint Louis University Mental Status Examination (SLUMs)

    Time frame: Change from Pre-operative score to 12 weeks post-operatively.

    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.

Secondary outcomes

  1. Opioid Use

    Time frame: Change from pre-operative score through 12 weeks post-operatively

    Opioid use will be calculated pre- and post-operatively using the Morphine Milligram Equivalents from patient self-reports.

  2. Opioid Side Effects and Likability Questionnaire

    Time frame: Change from 1 week post-operative results to 4 weeks post-operation.

    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.

  3. Self-reported Adverse Events

    Time frame: Change from pre-operative result through 12 weeks post-operatively.

    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

  4. Length of Hospitalization

    Time frame: Through study completion, 16 months

    The length of time patients were hospitalized will be collected through the electronic health record.

  5. Disposition to skilled-facilities

    Time frame: Through study completion, 16 months

    Where patients are dispositioned post-operatively will be collected through the electronic health record.

  6. 90-day Readmission Rates

    Time frame: Through study completion, 16 months

    The 90-day readmission rates will be collected through the electronic health record.

  7. Blood test for Inflammation

    Time frame: Measured Immediately before surgery and 1 day post-operatively

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alex R Coffman, BS

CONTACT

[email protected]

319-353-8996

Catherine R Olinger, MD

CONTACT

[email protected]

319-384-5892

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2022
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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