Bridge Device for Surgical Pain for Rotator Cuff Surgery

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.

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.

The case group (n = 15) will receive an activated Bridge device after surgery and continuing wearing the device until post-operative day (POD) 7.

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.

This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.

This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.

This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.

This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.

This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.

Pain scores will be completed on a Numeric Rating Scale (NRS) of 0=no pain at all and 10=the most severe pain.

Pain scores will be completed on a Numeric Rating Scale (NRS) of 0=no pain at all and 10=the most severe pain.

Pain scores will be completed on a Numeric Rating Scale (NRS) of 0=no pain at all and 10=the most severe pain.

Pain scores will be completed on a Numeric Rating Scale (NRS) of 0=no pain at all and 10=the most severe pain.

Pain scores will be completed on a Numeric Rating Scale (NRS) of 0=no pain at all and 10=the most severe pain.

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

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

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

Recorded as yes/no for adverse events related to opioids like nausea, vomiting, dizziness, and itching

Recorded as yes/no for adverse events related to opioids like nausea, vomiting, dizziness, and itching

Recorded as yes/no for adverse events related to opioids like nausea, vomiting, dizziness, and itching

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