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

ConditionsDeliriumPain, BackSpinal FusionThoracolumbar Interfascial Plane Block
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Iowa

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

64 years old and younger

emergency treatment

pathologic fractures

seeking revision surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    Questionnaire that will rate each symptom of delirium

  • Generalized Anxiety Disorder 7-item (GAD-7) scale

    Other intervention

    Questionnaire for screening and severity measurement of generalized anxiety disorder.

  • Numerical Rating Score (NRS)

    Other intervention

    Questionnaire assessing pain intensity

  • PROMIS-Pain Interference

    Other intervention

    Questionnaire measuring the effect of pain on patient physical, emotional, and social functioning.

  • Oswestry Disability Index (ODI)

    Other intervention

    Questionnaire assessing disability and quality of life impairment in adults with lower back pain.

  • Saint Louis University Mental Status Examination (SLUMs)

    Other intervention

    Questionnaire assessing baseline cognition.

  • Delirium Rating Scale-Revised-98 (DRS)

    Other intervention

    16 item clinician rated scale assessing delirium severity.

  • Telephone Interview for Cognitive Status - Modified (TICS-M)

    Other intervention

    Telephone interview questionnaire evaluating patient cognitive status.

  • Opioid Equivalents measured by Morphine Milligram Equivalents (MME)

    Other intervention

    The amount of opioids administered will be collected through patient self-report

  • Patient Health Questionnaire depression scale (PHQ-8)

    Other intervention

    Questionnaire used to diagnose and determine the severity measure for depressive disorders.

  • Pain Catastrophizing

    Other intervention

    Scale used to determine pain catastrophizing and it's severity.

  • Fear Avoidance Beliefs Questionnaire (FABQ)

    Other intervention

    Questionnaire used to help predict patients that have a high pain avoidance behavior.

  • Opioid Side Effects and Likeability Questionnaire

    Other intervention

    Survey determining adverse events related to opioid side effects and complications.

  • Daily Pain Trajectory

    Other intervention

    Questionnaire assessing pain location, severity, impact to quality of life, and medications used to alleviate.

  • Tampa Scale of Kinesiophobia

    Other intervention

    Questionnaire assessing Kinesiophobia

  • Quality of Recovery 15

    Other intervention

    Questionnaire assessing postoperative quality of recovery

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.Active comparator 17 interventions
Group B: Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaineExperimental treatment 18 interventions

Trial outcomes

Primary outcomes

1

Numerical 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.
2

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
3

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
4

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

Secondary outcomes

1

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
2

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.
3

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.
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Iowa

Lead sponsor

Source ClinicalTrials.gov
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