Status:
COMPLETED
Bridge Device for Surgical Pain for Rotator Cuff Surgery
Lead Sponsor:
Steven Orebaugh
Collaborating Sponsors:
Masimo Corporation
Conditions:
Pain
Rotator Cuff Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of the trial is to investigate the efficacy of the Bridge device in reducing post-operative pain and post-operative opioid consumption in patients undergoing rotator cuff surgery with th...
Detailed Description
The interscalene block is the gold standard for postoperative pain management following rotator cuff surgery. However, the duration of the block does not cover rehabilitation. Therefore, in most cases...
Eligibility Criteria
Inclusion
- Greater than 18 years of age
- Willing and able to provide informed consent
- Scheduled to undergo elective rotator cuff surgery at UPMC
- No pre-existing medical conditions which would prevent application of the Bridge device on auricle of ear (i.e., skin infection, rash)
Exclusion
- Opioids dependence
- Chronic pain condition with daily opioid use
- Anatomical malformation, which may interfere with placement of the nerve block
- Raynaud's disease diagnosis
- Vasculopathy
- Hemophilia or other coagulopathy, or use of active anticoagulation other than aspirin
- Patient refusal
- Pacemaker
- Pre-existing medical conditions which would prevent application of the Bridge device on auricle of ear (i.e., skin infection, rash)
- Psoriasis vulgaris
Key Trial Info
Start Date :
July 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06071884
Start Date
July 29 2024
End Date
September 26 2024
Last Update
February 11 2025
Active Locations (1)
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1
UPMC Outpatient Center
West Mifflin, Pennsylvania, United States, 15236