Status:
COMPLETED
Randomized Controlled Trial for Exparel Hip Fracture
Lead Sponsor:
University of Massachusetts, Worcester
Collaborating Sponsors:
Orthopaedic Trauma Association
University of Kentucky
Conditions:
Hip Fractures
Eligibility:
All Genders
55+ years
Phase:
PHASE4
Brief Summary
This is a prospective, randomized study looking at the effect that a long-acting local anesthetic has on pain control in patients having surgery for hip fractures. The investigators are conducting the...
Detailed Description
Osteoporotic fragility fractures of the hip are common in the geriatric population, are increasing in frequency, and represent a growing social and economic burden. Pain control after surgical treatme...
Eligibility Criteria
Inclusion
- Age 55 or older
- Sustaining either an OTA/AO type 31A or 31B fracture undergoing ORIF or hemiarthroplasty
- Able to consent
- Isolated injury
Exclusion
- OTA/AO 31B1 (Impacted/slightly displaced)
- Baseline dementia or cognitive deficit
- Inability to consent
- Chronic Opioid use
- End stage liver disease with Model for End-Stage Liver Disease (MELD) greater than 20.
- End stage renal disease as defined by patients requiring hemodialysis at least twice weekly
- Polytrauma, defined as: concurrent upper or lower extremity fracture, pelvis fracture, spine fracture, rib fractures, or facial fractures, Blunt chest or abdominal trauma resulting in diagnosed organ injury, Head trauma resulting in intracranial bleed or diagnosed concussion
- Allergy to amide-type local anesthetics
- Prisoners (unlikely to be accessible for follow-up)
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2019
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03289858
Start Date
September 1 2017
End Date
January 22 2019
Last Update
March 18 2021
Active Locations (2)
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1
University of Kentucky
Lexington, Kentucky, United States, 40536
2
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655