Status:
WITHDRAWN
Improving Pain Management After Total Shoulder Replacement Using Bupivacaine Liposome
Lead Sponsor:
University of Massachusetts, Worcester
Conditions:
Osteoarthritis of the Shoulder
Shoulder Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To improve pain control and decrease opioid requirements for subjects undergoing Total Shoulder Replacement.
Detailed Description
For the pilot study the investigators will use a total of 20 cases per group. A HIPAA Waiver will be used for screening purposes. The investigators will be using the electronic medical record system ...
Eligibility Criteria
Inclusion
- Adult subjects older than 18years old undergoing Total Shoulder Replacement (TSR) or reverse TSR surgery.
- Meet criteria for regional nerve block.
- Weight greater than 60kg (safety to keep liposomal bupivacaine and bupivacaine dosing below 3mg/kg).
Exclusion
- Recent drug use
- Subjects on chronic buprenorphine therapy (either for opioid replacement or pain control).
- Nerve injury (cervical stenosis, trauma, etc) of the surgical limb.
- Coagulopathy
- Subjects with significant liver disease (as amide type local anesthetics such as bupivacaine are metabolized by the liver).
- Infection near or in the area of the nerve block.
- Subject refusal of regional anesthesia.
- Vulnerable populations (prisoners, mental impairment / dementia, etc).
- Subjects requiring interpreter services (not proficient in English).
- Subjects with poor cardio-pulmonary reserve who might not tolerate a hemi-diaphragmatic paralysis or hemi-diaphragmatic paresis.
Key Trial Info
Start Date :
December 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04134442
Start Date
December 9 2019
End Date
September 23 2021
Last Update
July 6 2022
Active Locations (1)
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1
UMASS Memorial Medical Center
Worcester, Massachusetts, United States, 01655