Status:
COMPLETED
Exparel for Total Shoulder Arthroplasty
Lead Sponsor:
Norton Healthcare
Conditions:
Total Shoulder Arthroplasty
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to determine if Exparel leads to better pain scores at 24, 48 and 72 hours after Total Shoulder Arthroplasty (TSA) compared to a pain pump. Secondary objectives ...
Detailed Description
The primary objective of this study is to determine if Exparel leads to better pain scores at 24, 48 and 73 hours after TSA compared to a pain pump. Secondary objectives are (1) to determine if patien...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients undergoing unilateral primary TSA or reverse TSA
- Indication for surgery is osteoarthritis, rotator cuff arthropathy or massive irreparable rotator cuff tears
- Surgery performed by the Principal Investigator
- Anesthesia administered by Co-Principal Investigator
- Willing and able to sign an Informed Consent
- Exclusion criteria
- Indication for surgery is fracture
- Comorbid psychiatric diagnosis requiring therapy and/or medication except anxiety or depression
- Comorbid chronic pain syndrome (reflex sympathetic dystrophy, fibromyalgia)
- Has hepatic disease
- On workers compensation/disability/litigation
- Known adverse reaction to medications to be administered
- On long-acting narcotic pain medication (including extended release narcotic pain medications and methadone)
- Home Oxygen requirement whether as needed or scheduled.
- Contralateral Phrenic Nerve paralysis / incompetence.
- Body Mass Index ≥ 50
Exclusion
Key Trial Info
Start Date :
August 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2021
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04364867
Start Date
August 12 2020
End Date
February 17 2021
Last Update
November 26 2024
Active Locations (1)
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1
Norton Healthcare
Louisville, Kentucky, United States, 40202