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NCT02168959 · ClinicalTrials.gov registry record · Early Phase 1
Continuous Femoral Nerve Block With a Tibial Plateau Fracture
A Early Phase 1 study of Tibial Plateau Fracture, sponsored by University of Utah.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT02168959 is a Early Phase 1 study of Tibial Plateau Fracture that has completed, run by University of Utah. The registered enrollment target is 5 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02168959, a Early Phase 1 study of Tibial Plateau Fracture, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary purpose of the proposed study is to compare postoperative pain scores and total opioid consumption between two groups randomized to either receive or not receive a femoral nerve block for pain control following surgical repair of a tibial plateau fracture. Pain will be assessed post-operatively using standard numeric pain scores rated on a 0 - 10 scale, as well as using the University new pain assessment tool - the Clinically Aligned Pain Assessment (CAPA). This new 5 question pain assessment tool has not yet been validated, but does address several key questions, including patient comfort, pain control, change in pain status, daily functioning, and sleep quality. Along with post-operative pain scores, we will compare total opioid consumption between the two groups. The null hypothesis is that there is no difference in pain scores or total opioid consumption between patients receiving a femoral nerve block and those without a nerve block following surgical repair of a tibial plateau fracture. A secondary outcome will examine long-term pain control, range of motion, and functional status of these patients at their regular orthopedic clinic follow-up appointments. The same pain scores will be assessed, along with quadriceps strength and knee range of motion. Patients will complete the PROMIS Physical Function CAT and short Musculoskeletal Function Assessment, patient reported outcomes tools to evalute physical function. A teriary outcome will be to retrospectively examine postoperative pain scores and total opioid consumption for all tibial plateau fracture patients seen at the University of Utah for surgical repair in the past 10 years.
Conditions Studied
Interventions
- DRUG bupivacaine
Study Locations (1)
Utah
- University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2013-02 |
| Est. Completion | 2014-12 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02168959
The ClinicalTrials.gov registry entry for NCT02168959 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Tibial Plateau Fracture appearing as the primary indexed condition, and to 1 intervention - of which bupivacaine is the first listed.
NCT02168959 reports 1 study location spanning 1 distinct geographic area - top geographies include Utah.
Frequently Asked Questions
What is clinical trial NCT02168959 about?
NCT02168959 is a clinical study titled "Continuous Femoral Nerve Block With a Tibial Plateau Fracture". The primary purpose of the proposed study is to compare postoperative pain scores and total opioid consumption between two groups randomized to either receive or not receive a femoral nerve block for pain control following surgical repair of a tibial plateau fracture. Pain will be assessed post-oper...
What is the current status of trial NCT02168959?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 5 participants. The study started on 2013-02. Estimated completion is 2014-12.
What conditions does trial NCT02168959 study?
This clinical trial studies the following conditions: Tibial Plateau Fracture.
What interventions are being tested in trial NCT02168959?
The interventions under investigation include: bupivacaine (DRUG).
Who is sponsoring clinical trial NCT02168959?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02168959 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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