Continuous Femoral Nerve Block With a Tibial Plateau Fracture
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|ClinicalTrials.gov Identifier: NCT02168959|
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : March 14, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Tibial Plateau Fracture||Drug: bupivacaine||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Postoperative Pain Management With a Continuous Femoral Nerve Block in Patients With a Tibial Plateau Fracture|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Active Comparator: Femoral nerve block
This drug is standard of care. The point of the study is to see if this method will yield better pain scores and improved patient satisfaction vs. non-nerve block. Simply: prospective observation of two standard methods.
No Intervention: No femoral nerve block
- Postoperative Pain Score and patient satisfaction [ Time Frame: Follow-up Visits up to 1-Year ]
- Long-term Pain Control [ Time Frame: Follow-up Visits up to 1-Year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168959
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84108|
|Principal Investigator:||Erik Kubiak||Orthopedic Surgery|