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RECRUITING Early Phase 1

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

NCT05461092 · View on ClinicalTrials.gov ↗

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.

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)

Study Locations (1)

Iowa

  • University of Iowa — Iowa City

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2024-01-01
Est. Completion 2026-12-31
Phase Early Phase 1

Sponsor

University of Iowa

156 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05461092

The ClinicalTrials.gov registry entry for NCT05461092 describes a study currently listed as recruiting. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Iowa, which has 156 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Delirium appearing as the primary indexed condition, and to 5 interventions — of which Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05461092 reports 1 study location spanning 1 distinct geographic area — top geographies include Iowa. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05461092 about?

NCT05461092 is a clinical study titled "Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion". 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 sho...

What is the current status of trial NCT05461092?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 50 participants. The study started on 2024-01-01. Estimated completion is 2026-12-31.

What conditions does trial NCT05461092 study?

This clinical trial studies the following conditions: Delirium, Spinal Fusion, Pain, Back, Thoracolumbar Interfascial Plane Block. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05461092?

The interventions under investigation include: Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine (DRUG), Blood Test (DIAGNOSTIC_TEST), 3D CAM Delirium Severity Scoring (OTHER), Generalized Anxiety Disorder 7-item (GAD-7) scale (OTHER), Numerical Rating Score (NRS) (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05461092?

This trial is sponsored by University of Iowa, which has 156 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05461092 being conducted?

This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial