Continuous Femoral Nerve Block With a Tibial Plateau Fracture

NCT02168959 | Completed Early Phase 1

• 1 other identifier: 56481
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Tibial Plateau Fracture

Keywords

Femoral Nerve Block; Pain Control; Tibial Plateau Fracture; Prospective; Randomized

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Score and patient satisfaction

  Follow-up Visits up to 1-Year

Secondary Outcomes (1)

• Long-term Pain Control

  Follow-up Visits up to 1-Year

Study Arms (2)

Femoral nerve block

ACTIVE COMPARATOR

bupivacaine

Drug: bupivacaine

No femoral nerve block

NO INTERVENTION

No block

Interventions

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.

Femoral nerve block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Tibial Plateau Fractures; Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Erik Kubiak

  Orthopedic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: June 18, 2014
• First Posted: June 20, 2014
• Study Start: February 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 14, 2016

Record last verified: 2016-03

Locations

US (1)