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-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.

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Key information

Conditions

Tibial Plateau Fracture Agnosia Fractures, Bone Knee Fractures Knee Injuries Leg Injuries Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Tibial Fractures Tibial Plateau Fractures Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Utah

Salt Lake City, Utah, 84108, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male and female patients, aged 18 years or older, who are presenting to the University Hospital for surgical repair of a tibial plateau fracture will be considered for inclusion in the prospective study. The diagnosis of a tibial plateau fracture and the decision to proceed to the operating room for surgery will be made by the attending surgeon of the orthopedic trauma service based on his expertise and standard of care.
Male and female patients, aged 18 years or older, who have underwent surgery performed by Dr. Kubiak or Dr. Higgins at University Hospital for repair of a tibial plateau fracture will be considered for inclusion in the retrospective study.

Exclusion criteria

Prospective Study:

Patients who do not speak English
Patients who are unable to effectively communicate with their treatment team (example: mechanically ventilated patients and mentally handicapped patients)
Patients less than 18 years old
Patients with ongoing compartment syndrome
Patients with an allergy or intolerance to bupivacaine
Patients with other significant associated traumatic injuries that would be expected to delay their overall recovery (example: a patient who sustains a motor vehicle accident and fractures their tibia but also sustains massive intra-abdominal injury with serious damage to their liver and other vital organs)
Patients with ipsilateral femoral fractures

Retrospective:

Patients less than 18 years of age

Treatment and study plan

Bupivacaine

Drug

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.

Primary outcomes

Postoperative Pain Score and patient satisfaction

Time frame: Follow-up Visits up to 1-Year

Secondary outcomes

Long-term Pain Control

Time frame: Follow-up Visits up to 1-Year

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Postoperative Pain Management With a Continuous Femoral Nerve Block in Patients With a Tibial Plateau Fracture

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Jun 20, 2014
Registry last updated: Mar 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed