Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine for Delirium

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Iowa, Iowa City, IA
Delirium+4 More
3D CAM Delirium Severity Scoring - Other
Eligibility
65+
All Sexes
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Study 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.

Eligible Conditions

  • Delirium
  • Back pain
  • Fusion of Spine (Disease)
  • Thoracolumbar Interfascial Plane Block

Treatment Effectiveness

Study Objectives

13 Primary · 7 Secondary · Reporting Duration: Through study completion, 16 months

Day 30
Daily Pain Trajectory
Week 12
Numerical Rating Score
Week 4
Opioid Side Effects and Likability Questionnaire
Week 12
Pain Catastrophizing
Pain Fear and Avoidance
Pain Interference
Week 12
3D-CAM-S and 3D-CAM-ICU
Delirium Rating Scale-Revised-98
Modified Telephone Interview of Cognitive Status
Oswestry disability index
Tampa Scale of Kinesiophobia
Week 12
Saint Louis University Mental Status Examination (SLUMs)
Week 12
Generalized Anxiety Disorder
Personal Health Questionnaire Depression Scale
Week 12
Self-reported Adverse Events
Week 12
Opioid Use
Day 1
Blood test for Inflammation
Month 16
90-day Readmission Rates
Disposition to skilled-facilities
Length of Hospitalization

Trial Safety

Trial Design

2 Treatment Groups

Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Bloc...
1 of 2
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block o...
1 of 2
Active Control
Experimental Treatment

50 Total Participants · 2 Treatment Groups

Primary Treatment: Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine · No Placebo Group · Phase < 1

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaineExperimental Group · 17 Interventions: 3D CAM Delirium Severity Scoring, Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine, Patient Health Questionnaire depression scale (PHQ-8), Opioid Side Effects and Likeability Questionnaire, Opioid Equivalents measured by Morphine Milligram Equivalents (MME), Numerical Rating Score (NRS), Oswestry Disability Index (ODI), Blood Test, Fear Avoidance Beliefs Questionnaire (FABQ), Tampa Scale of Kinesiophobia, Delirium Rating Scale-Revised-98 (DRS), Daily Pain Trajectory, Generalized Anxiety Disorder 7-item (GAD-7) scale, Saint Louis University Mental Status Examination (SLUMs), PROMIS-Pain Interference, Pain Catastrophizing, Telephone Interview for Cognitive Status - Modified (TICS-M) · Intervention Types: Other, Drug, Other, Other, Other, Other, Other, DiagnosticTest, Other, Other, Other, Other, Other, Other, Other, Other, Other
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.ActiveComparator Group · 16 Interventions: 3D CAM Delirium Severity Scoring, Patient Health Questionnaire depression scale (PHQ-8), Opioid Side Effects and Likeability Questionnaire, Opioid Equivalents measured by Morphine Milligram Equivalents (MME), Numerical Rating Score (NRS), Oswestry Disability Index (ODI), Blood Test, Fear Avoidance Beliefs Questionnaire (FABQ), Tampa Scale of Kinesiophobia, Delirium Rating Scale-Revised-98 (DRS), Daily Pain Trajectory, Generalized Anxiety Disorder 7-item (GAD-7) scale, Saint Louis University Mental Status Examination (SLUMs), PROMIS-Pain Interference, Pain Catastrophizing, Telephone Interview for Cognitive Status - Modified (TICS-M) · Intervention Types: Other, Other, Other, Other, Other, Other, DiagnosticTest, Other, Other, Other, Other, Other, Other, Other, Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blood Test
2010
N/A
~320

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, 16 months

Trial Background

Prof. Catherine R. Olinger, Clinical Assistant Professor
Principal Investigator
University of Iowa
Closest Location: University of Iowa · Iowa City, IA
Photo of University of Iowa  1Photo of University of Iowa  2Photo of University of Iowa  3
1993First Recorded Clinical Trial
4 TrialsResearching Delirium
447 CompletedClinical Trials

Eligibility Criteria

Age 65+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
If you are 65 or older, you may not participate in this study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References