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Bridge Device for Surgical Pain After Rotator Cuff Injury
N/A
Recruiting
Led By Steven L Orebaugh, MD
Research Sponsored by Steven Orebaugh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Greater than 18 years of age
No pre-existing medical conditions which would prevent application of the Bridge device on auricle of ear (i.e., skin infection, rash)
Must not have
Patient refusal
Hemophilia or other coagulopathy, or use of active anticoagulation other than aspirin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-operative day 7
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at a device to reduce pain and opioid use after rotator cuff surgery with nerve block and sedation.
Who is the study for?
This trial is for adults over 18 scheduled for elective rotator cuff surgery at UPMC, who can consent and have no skin issues on the ear where the Bridge device will be placed. It's not for those dependent on opioids, with chronic pain and daily opioid use, certain blood disorders, pacemakers, or conditions like Raynaud's disease.
What is being tested?
The study tests if the Bridge device can lessen post-surgery pain and reduce opioid use after rotator cuff surgery. Participants receive standard anesthesia plus this non-drug treatment that stimulates nerves through the skin of their ear.
What are the potential side effects?
Potential side effects may include discomfort or skin irritation at the site where the Bridge device is applied to the ear. Since it's a non-pharmaceutical approach, drug-related side effects are not expected.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
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My ears are healthy, with no infections or rashes that would prevent using a medical device on them.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have chosen not to participate in the trial.
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I have a bleeding disorder or I'm on blood thinners other than aspirin.
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My ears are healthy, with no infections or rashes that would prevent device use.
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I have a condition affecting my blood vessels.
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I use opioids daily for chronic pain.
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I have been diagnosed with Raynaud's disease.
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I have been diagnosed with psoriasis vulgaris.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-operative day 7
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-operative day 7
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Oral Opioid Use POD 1
Oral Opioid Use POD 2
Oral Opioid Use POD 3
+2 moreSecondary study objectives
Adverse events related to opioid POD 5
Adverse events related to opioid POD 6
Adverse events related to opioid POD 7
+15 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Bridge Percutaneous Nerve Field StimulatorExperimental Treatment1 Intervention
The case group (n = 15) will receive an activated Bridge device after surgery and continuing wearing the device until post-operative day (POD) 7.
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Who is running the clinical trial?
Steven OrebaughLead Sponsor
1 Previous Clinical Trials
54 Total Patients Enrolled
Masimo CorporationIndustry Sponsor
116 Previous Clinical Trials
13,519 Total Patients Enrolled
Steven L Orebaugh, MDPrincipal InvestigatorUniversity of Pittsburgh
Amy Monroe, MPH, MBAStudy DirectorUniversity of Pittsburgh
4 Previous Clinical Trials
1,760 Total Patients Enrolled