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NCT05461092EARLY_PHASE1Recruiting

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

University of Iowa

Start Date

1/1/2024

Completion Date

12/31/2026

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.

Eligibility Criteria

Age Range: 65 years to No maximum

Inclusion Criteria: * 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 * no severe cardiac or respiratory disease * no preexisting cognitive dysfunction/dementia Exclusion Criteria: * 64 years old and younger * emergency treatment * pathologic fractures * seeking revision surgery * major liver or kidney dysfunction * coexisting hematological disorder or irreversible abnormal coagulation * patients with previous diagnosis of dementia or SLUMS score \<20 * patient unable to communicate/cooperate/language barrier * BMI\>40 * allergy to study medications * opioid tolerant (oral opioid intake morphine equivalent =\< 60 mg/day) * other sources of chronic pain like fibromyalgia * patients with associated significant CNS or respiratory disease (home oxygen requirements) * incarcerated patients * psychiatric illnesses preoperative neurological deficits greater than one motor group, less than three out of five motor functions * pregnant or breast feeding

Interventions

DRUG

Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine

DIAGNOSTIC_TEST

Blood Test

OTHER

3D CAM Delirium Severity Scoring

OTHER

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

OTHER

Numerical Rating Score (NRS)

OTHER

PROMIS-Pain Interference

OTHER

Oswestry Disability Index (ODI)

OTHER

Saint Louis University Mental Status Examination (SLUMs)

OTHER

Delirium Rating Scale-Revised-98 (DRS)

OTHER

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

OTHER

Opioid Equivalents measured by Morphine Milligram Equivalents (MME)

OTHER

Patient Health Questionnaire depression scale (PHQ-8)

OTHER

Pain Catastrophizing

OTHER

Fear Avoidance Beliefs Questionnaire (FABQ)

OTHER

Opioid Side Effects and Likeability Questionnaire

OTHER

Daily Pain Trajectory

OTHER

Tampa Scale of Kinesiophobia

OTHER

Quality of Recovery 15

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Conditions

DeliriumPain, BackSpinal FusionThoracolumbar Interfascial Plane Block

Locations

University of Iowa

Iowa City, Iowa 52242

United States