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

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

January 1, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
DeliriumPain, BackSpinal FusionThoracolumbar 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

Trial Locations (1)

52242

RECRUITING

University of Iowa, Iowa City

All Listed Sponsors
lead

University of Iowa

OTHER