Status:
WITHDRAWN
A Study of Postsurgical Pain Control for Lower Extremity Fractures
Lead Sponsor:
Broward Health
Conditions:
Lower Extremity Fractures.
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Postsurgical pain may effectively be treated with a multimodal approach that incorporates the use of local anesthetics. Bupivacaine is a local anesthetic that has been proven to be effective at reduci...
Detailed Description
All patients undergoing surgical fixation of a lower extremity fracture(s) will be offered the opportunity to enroll in the study. Patients undergoing unilateral or bilateral surgical fixation would b...
Eligibility Criteria
Inclusion
- Patients over 18 years of age
- Preoperative diagnosis of lower extremity fracture(s) requiring surgical fixation
Exclusion
- Allergy to ExparelTM or certain other local anesthetic agents
- Surgery performed at an outside institution or by a different surgeon
- Chronic analgesic users (defined as use of opioid medication \>14 days in the past 3 months, or use of non-opioid pain medication \>5 times per week
- Pregnant females or females who think they may become pregnant
- Peripheral neuropathy
- Major psychiatric disease
- Inability to comprehend the nature of the study
- Unwillingness to provide signed informed consent
- Markedly abnormal kidney function or renal disease
- Non-English speaking
- Signs or symptoms of compartment syndrome
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02214810
Start Date
January 1 2015
End Date
September 1 2015
Last Update
February 19 2016
Active Locations (1)
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1
Broward Health Medical Center
Fort Lauderdale, Florida, United States, 33316