Recruiting
Early Phase 1

Regional Nerve Blocks

Sponsor:

University of Iowa

Code:

NCT05461092

Conditions

Delirium

Pain, Back

Spinal Fusion

Thoracolumbar Interfascial Plane Block

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine

Blood Test

3D CAM Delirium Severity Scoring

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

Numerical Rating Score (NRS)

Study Details

Brief 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

Study ID

NCT05461092

Start date

Jan 1, 2024

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.

experimental: Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine

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

Interventions

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.

Blood Test

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

3D CAM Delirium Severity Scoring

Questionnaire that will rate each symptom of delirium

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

Questionnaire for screening and severity measurement of generalized anxiety disorder.

Numerical Rating Score (NRS)

Questionnaire assessing pain intensity

PROMIS-Pain Interference

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

Oswestry Disability Index (ODI)

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

Saint Louis University Mental Status Examination (SLUMs)

Questionnaire assessing baseline cognition.

Delirium Rating Scale-Revised-98 (DRS)

16 item clinician rated scale assessing delirium severity.

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

Telephone interview questionnaire evaluating patient cognitive status.

Opioid Equivalents measured by Morphine Milligram Equivalents (MME)

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

Patient Health Questionnaire depression scale (PHQ-8)

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

Pain Catastrophizing

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

Fear Avoidance Beliefs Questionnaire (FABQ)

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

Opioid Side Effects and Likeability Questionnaire

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

Daily Pain Trajectory

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

Tampa Scale of Kinesiophobia

Questionnaire assessing Kinesiophobia

Quality of Recovery 15

Questionnaire assessing postoperative quality of recovery

Primary outcome measure

  • Numerical Rating Score [ Time Frame: Change assessed from pre-surgery to 12 weeks post-operatively. ]
  • Daily Pain Trajectory [ Time Frame: Change assessed from 1 day to 30 days post-operatively ]
  • Pain Catastrophizing [ Time Frame: Change from Pre-operation score to 12 weeks post-operatively ]
  • Pain Fear and Avoidance [ Time Frame: Change from Pre-operation score to 12 weeks post-operatively ]
  • Pain Interference [ Time Frame: Change from Pre-operation score to 12 weeks post-operatively ]
  • Generalized Anxiety Disorder [ Time Frame: Change from pre-operation score to 12 weeks post-operatively ]
  • Personal Health Questionnaire Depression Scale [ Time Frame: Change from pre-operation score to 12 weeks post-operatively ]
  • Oswestry disability index [ Time Frame: Change from Pre-operative score to 12 weeks post-operatively ]
  • Tampa Scale of Kinesiophobia [ Time Frame: Change from Pre-operative score to 12 weeks post-operatively ]
  • Delirium Rating Scale-Revised-98 [ Time Frame: Change from Pre-operative score to 12 weeks post-operatively ]
  • 3D-CAM-S and 3D-CAM-ICU [ Time Frame: Change from Pre-operative score to 12 weeks post-operatively ]
  • Modified Telephone Interview of Cognitive Status [ Time Frame: Change from Pre-operative score to 12 weeks post-operatively ]
  • Saint Louis University Mental Status Examination (SLUMs) [ Time Frame: Change from Pre-operative score to 12 weeks post-operatively. ]

Central Contacts and Locations

Central contacts

Alex R Coffman, BS

319-353-8996alex-coffman@uiowa.edu

Catherine R Olinger, MD

319-384-5892catherine-olinger@uiowa.edu

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

More Information

Sponsor

University of Iowa

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Iowa on 2026-03-27.