Bridge Device for Surgical Pain for Rotator Cuff Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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, patients are discharged from the surgical center with an opioid prescription. There is a growing need to investigate complementary, non-pharmacologic pain-management methods. The Bridge device, which provides auricular neuromodulation of various cutaneous nerves near the ear, is manufactured by Masimo and previously FDA-approved to reduce symptoms of opioid withdrawal. It is a promising technology that could help relieve post-operative pain without exposing patients to the adverse effects of opioids or other pain-relieving medications. 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. Those enrolled will be assigned to a study group and compared to historic cohort (control group). Historic control group involves patients that underwent same surgical procedure performed at the surgical center involved in the study, by the same surgical operator, between 2020 and 2023.

Official Title
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Evaluation of Bridge Device in Pain Management for Outpatient Rotator Cuff Surgery

Conditions
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Pain, Rotator Cuff Injuries

Intervention / Treatment
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* Device: Bridge Percutaneous Nerve Field Stimulator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bridge Percutaneous Nerve Field Stimulator<br>The case group (n = 15) will receive an activated Bridge device after surgery and continuing wearing the device until post-operative day (POD) 7. | Device: Bridge Percutaneous Nerve Field Stimulator<br>* The Bridge device is an FDA-cleared, drug-free, non-surgical device that uses neuro-modulation to aid in the reduction of symptoms associated with opioid withdrawal through application to branches of the Cranial Nerves V, VII, IX, X, and the occipital nerves. This study is investigating its effectiveness treating post-surgical pain.<br>* Other names: NSS-2 BRIDGE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral Opioid Use POD 1 | This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records. | Post-Operative Day 1 | 
| Oral Opioid Use POD 2 | This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records. | Post-Operative Day 2 | 
| Oral Opioid Use POD 3 | This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records. | Post-Operative Day 3 | 
| Oral Opioid Use POD 4 | This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records. | Post-Operative Day 4 | 
| Oral Opioid Use POD 5 | This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records. | Post-Operative Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Reported Pain Scores POD 1 | Pain scores will be completed on a Numeric Rating Scale (NRS) of 0=no pain at all and 10=the most severe pain. | Post-Operative Day 1 | 
| Self-Reported Pain Scores POD 2 | Pain scores will be completed on a Numeric Rating Scale (NRS) of 0=no pain at all and 10=the most severe pain. | Post-Operative Day 2 | 
| Self-Reported Pain Scores POD 3 | Pain scores will be completed on a Numeric Rating Scale (NRS) of 0=no pain at all and 10=the most severe pain. | Post-Operative Day 3 | 
| Self-Reported Pain Scores POD 4 | Pain scores will be completed on a Numeric Rating Scale (NRS) of 0=no pain at all and 10=the most severe pain. | Post-Operative Day 4 | 
| Self-Reported Pain Scores POD 5 | Pain scores will be completed on a Numeric Rating Scale (NRS) of 0=no pain at all and 10=the most severe pain. | Post-Operative Day 5 | 
| Self-Reported Oral Opioid Use POD 5 | Collected through the subject diary and recorded as total dosage (mg) taken | Post-Operative Day 5 | 
| Self-Reported Oral Opioid Use POD 6 | Collected through the subject diary and recorded as total dosage (mg) taken | Post-Operative Day 6 | 
| Self-Reported Oral Opioid Use POD 7 | Collected through the subject diary and recorded as total dosage (mg) taken | Post-Operative Day 7 | 
| Self-Reported Pain Scores POD 5 | Averaged NRS pain scores (0=no pain at all and 10=the most severe pain) collected via subject diary after hospital discharge every 8-hours | Post-Operative Day 5 | 
| Self-Reported Pain Scores POD 6 | Averaged NRS pain scores (0=no pain at all and 10=the most severe pain) collected via subject diary after hospital discharge every 8-hours | Post-Operative Day 6 | 
| Self-Reported Pain Scores POD 7 | Averaged NRS pain scores (0=no pain at all and 10=the most severe pain) collected via subject diary after hospital discharge every 8-hours | Post-Operative Day 7 | 
| Adverse events related to opioid POD 5 | Recorded as yes/no for adverse events related to opioids like nausea, vomiting, dizziness, and itching | Post-Operative Day 5 | 
| Adverse events related to opioid POD 6 | Recorded as yes/no for adverse events related to opioids like nausea, vomiting, dizziness, and itching | Post-Operative Day 6 | 
| Adverse events related to opioid POD 7 | Recorded as yes/no for adverse events related to opioids like nausea, vomiting, dizziness, and itching | Post-Operative Day 7 | 
| Local adverse events on ear related to device POD 1 | Recorded as yes/no for adverse events related to the device such as pain or skin irritation | Post-operative Day 1 | 
| Local adverse events on ear related to device POD 2 | Recorded as yes/no for adverse events related to the device such as pain or skin irritation | Post-operative Day 2 | 
| Local adverse events on ear related to device POD 3 | Recorded as yes/no for adverse events related to the device such as pain or skin irritation | Post-operative Day 3 | 
| Local adverse events on ear related to device POD 4 | Recorded as yes/no for adverse events related to the device such as pain or skin irritation | Post-operative Day 4 | 
| Local adverse events on ear related to device POD 5 | Recorded as yes/no for adverse events related to the device such as pain or skin irritation | Post-operative Day 5 |