Status:
WITHDRAWN
Continuous Cryotherapy in Shoulder Arthroplasty Patients
Lead Sponsor:
D. Patrick Williams
Collaborating Sponsors:
Lake Erie College of Osteopathic Medicine
Conditions:
Pain, Shoulder
Eligibility:
All Genders
55-80 years
Phase:
NA
Brief Summary
This is a randomized prospective study to test if cooling therapies decrease narcotic pain medication use in patients following total shoulder replacement surgery (total shoulder arthroplasty, TSA). P...
Detailed Description
Prior to the surgical procedure, the patients will be met by one of the coinvestigators or Dr. Williams in the preoperative holding area. At this time, the patients will be administered a questionnair...
Eligibility Criteria
Inclusion
- Patients between the age of 55 and 80 who are indicated for a TSA, including both anatomic (maintaining anatomic location of the ball and socket in the shoulder) and reverse (reverses where the ball and socked are placed) total shoulder arthroplasties.
Exclusion
- Patients undergoing:
- revision total shoulder arthroplasty
- TSA for a fracture
- Patients with a history of narcotic abuse.
- Patients unwilling or unable to receive and interscalene block
- Patients with Raynaud's disease, vasospastic disease, or other circulatory dysfunction
- Patients with cold hypersensitivity, decreased skin sensitivity related to temperature
- Patients with central ports, PICC lines, or other indwelling IV access on the affected side.
Key Trial Info
Start Date :
October 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04861441
Start Date
October 22 2021
End Date
June 24 2022
Last Update
June 23 2023
Active Locations (1)
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1
UPMC Hamot
Erie, Pennsylvania, United States, 16550