N/A
Completed N=42
Bridge Device for Surgical Pain for Rotator Cuff Surgery
Postoperative Pain · Rotator Cuff Injuries
Source: ClinicalTrials.gov NCT06071884 ↗
Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcomePrimary: Oral Opioid Use POD 1 — 35.7; 40.2 mg OME
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 the typical mode of anesthesia, nerve block plus propofol sedation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oral Opioid Use POD 1 |
35.7; 40.2 | — |
| PRIMARY Oral Opioid Use POD 3 |
21.5; 35.4 | — |
| PRIMARY Oral Opioid Use POD 5 |
6.0 | — |
| PRIMARY Oral Opioid Use POD 7 |
0.5 | — |
| SECONDARY Self-Reported Pain Scores POD 1 |
4.57; 6.42 | — |
| SECONDARY Self-Reported Pain Scores POD 3 |
3.18; 6.75 | — |
| SECONDARY Self-Reported Pain Scores POD 5 |
2.42 | — |
| SECONDARY Number of Participants Who Self-Reported Oral Opioid Use POD 5 |
7; 8 | — |
| SECONDARY Number of Participants Who Self-Reported Oral Opioid Use POD 7 |
3; 12 | — |
| SECONDARY Adverse Events Related to Opioid POD 5 |
0; 15 | — |
| SECONDARY Adverse Events Related to Opioid POD 7 |
3; 12 | — |
| SECONDARY Local Adverse Events on Ear Related to Device POD 1 |
0; 15 | — |
| SECONDARY Local Adverse Events on Ear Related to Device POD 3 |
0; 15 | — |
| SECONDARY Local Adverse Events on Ear Related to Device POD 5 |
0; 15 | — |
| SECONDARY Local Adverse Events on Ear Related to Device POD 7 |
3; 12 | — |
| SECONDARY Self-Reported Pain Scores POD 7 |
1.8 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT06071884). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.