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Continuous Femoral Nerve Block With a Tibial Plateau Fracture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02168959
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):
Eric Kubiak, University of Utah

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.


Condition or disease Intervention/treatment Phase
Tibial Plateau Fracture Drug: bupivacaine Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Femoral nerve block
bupivacaine
Drug: 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.

No Intervention: No femoral nerve block
No block



Primary Outcome Measures :
  1. Postoperative Pain Score and patient satisfaction [ Time Frame: Follow-up Visits up to 1-Year ]

Secondary Outcome Measures :
  1. Long-term Pain Control [ Time Frame: Follow-up Visits up to 1-Year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Erik Kubiak Orthopedic Surgery
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Responsible Party: Eric Kubiak, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT02168959    
Other Study ID Numbers: 56481
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: March 14, 2016
Last Verified: March 2016
Keywords provided by Eric Kubiak, University of Utah:
Femoral Nerve Block
Pain Control
Tibial Plateau Fracture
Prospective
Randomized
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents