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

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.

Conditions

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

Interventions

DRUG

Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine

Patient receives standard of care anesthesia with TLIP Block of bupivicaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.

DIAGNOSTIC_TEST

Blood Test

Blood Tests measuring inflammatory markers: IL-10, MCP-1, IL-8, IL-6, TNFa

OTHER

3D CAM Delirium Severity Scoring

Questionnaire that will rate each symptom of delirium

OTHER

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

Questionnaire for screening and severity measurement of generalized anxiety disorder.

OTHER

Numerical Rating Score (NRS)

Questionnaire assessing pain intensity

OTHER

PROMIS-Pain Interference

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

OTHER

Oswestry Disability Index (ODI)

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

OTHER

Saint Louis University Mental Status Examination (SLUMs)

Questionnaire assessing baseline cognition.

OTHER

Delirium Rating Scale-Revised-98 (DRS)

16 item clinician rated scale assessing delirium severity.

OTHER

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

Telephone interview questionnaire evaluating patient cognitive status.

OTHER

Opioid Equivalents measured by Morphine Milligram Equivalents (MME)

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

OTHER

Patient Health Questionnaire depression scale (PHQ-8)

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

OTHER

Pain Catastrophizing

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

OTHER

Fear Avoidance Beliefs Questionnaire (FABQ)

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

OTHER

Opioid Side Effects and Likeability Questionnaire

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

OTHER

Daily Pain Trajectory

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

OTHER

Tampa Scale of Kinesiophobia

Questionnaire assessing Kinesiophobia

OTHER

Quality of Recovery 15

Questionnaire assessing postoperative quality of recovery

Sponsors & Collaborators

• University of Iowa

  lead OTHER

Principal Investigators

• Catherine R Olinger, MD · Clinical Assistant Professor

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-01

Primary Completion

2026-12-31

Completion

2026-12-31

FDA Drug

Yes

Countries

• United States

Study Locations