NCT05461092

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-07-15
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study