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NCT05461092 · ClinicalTrials.gov registry record · Early Phase 1
Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion
A Early Phase 1 study of Delirium and Spinal Fusion, sponsored by University of Iowa.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05461092: Recruiting Early Phase 1 study of Delirium and Spinal Fusion, sponsored by University of Iowa.
NCT05461092 is a Early Phase 1 study of Delirium and Spinal Fusion that is actively recruiting participants, run by University of Iowa. The registered enrollment target is 50 participants, below the 887-participant average among 62 other Delirium trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05461092, a Early Phase 1 study of Delirium and Spinal Fusion, is actively recruiting participants, sponsored by University of Iowa.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Change in pain will be assessed using the Numerical Rating Score Questionnaire immediately before surgery and at 2, 6 and 12 weeks post-operatively.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-01-01 |
| Est. Completion | 2026-12-31 |
| Phase | Early Phase 1 |
What NCT05461092 shows while recruiting
NCT05461092 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 887-participant average among 62 other Delirium trials with a reported enrollment target (94% lower).
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.
NCT05461092 reports a single indexed study location in Iowa.
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.
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).
Who is sponsoring clinical trial NCT05461092?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05461092's enrollment target sits among peer trials
50 49th of 62 higher than 13 of 62 other Delirium trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Delirium trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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