Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-01-17 @ 12:44 PM
Study NCT ID:
NCT02168959
Status:
COMPLETED
Last Update Posted:
2016-03-14
First Post:
2014-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Femoral Nerve Block With a Tibial Plateau Fracture
Sponsor:
University of Utah
Organization:
Study Overview
Official Title:
Postoperative Pain Management With a Continuous Femoral Nerve Block in Patients With a Tibial Plateau Fracture
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: