Continuous Femoral Nerve Block With a Tibial Plateau Fracture

NCT ID: NCT02168959

Last Updated: 2016-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Femoral nerve block

bupivacaine

Group Type: ACTIVE_COMPARATOR

bupivacaine

Intervention Type: 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.

No femoral nerve block

No block

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

bupivacaine

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Eric Kubiak

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erik Kubiak

Role: PRINCIPAL_INVESTIGATOR

Orthopedic Surgery

Locations

University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

56481

Identifier Type: -

Identifier Source: org_study_id