Evaluation of Bridge Device in Pain Management for Outpatient Rotator Cuff Surgery
Phase: NA
Conditions: Pain, Rotator Cuff Injuries
Sponsor: Steven Orebaugh

 
 
 
 
 
STUDY TITLE: Evaluation of Bridge Device in Pain Management for Outpatient Rotator Cuff Surgery 
IRB: STUDY23030139 
NCT06071884 
Protocol & Statistical Analysis: 18 SEP 2023 
 
 
 
 

Proposal: Use of the “Bridge” device for pain management after ambulatory rotator cuff repair. 
 
Investigators: Mariusz Ligocki (CA2), Steven Orebaugh, Henry Guo (CBY), Jacques Chelly, Amy 
Monroe, Mark Rodosky 
 
Background: 
 
Peripheral nerve blocks are effective for pain of shoulder surgery, including rotator cuff repair. 
However, single shot blocks are limited in duration, and their termination leads to rapid 
resumption of pain, sometimes termed "rebound" pain (1. ). Catheters are more effective in 
providing long term pain control, but generally are removed by postoperative day three to 
avoid infection and due to pump reservoir limitations. In addition, they involve considerably 
more time, effort, personnel and cost, compared to single-shot blocks. Liposomal bupivacaine is 
a long-acting analgesic proposed to provide 72 hours of pain relief, but studies have been 
disappointing (2.). In a study conducted at our institution, Auricular stimulation, an alternative 
technique related to acupuncture, has been shown to reduce opioid consumption for the first 
three days after kidney donation surgery (3). A recent observational study including ambulatory 
shoulder surgery evaluated the "Bridge" device (manufactured by Masimo, previously FDA 
approved to reduce symptoms of opioid withdrawal)  for postoperative pain control after 
application of single-shot nerve block (4.). The authors reported a markedly low opioid 
requirement among the patients, as well as very low postoperative pain scores. The device has 
proven simple to place, symptom-free, well-tolerated, and easy for patients to wear and 
remove at home. For these reasons, we would like to further explore the use of this non-
invasive, alternative device for pain control among outpatient rotator cuff surgery patients. 
 
The Bridge device, currently FDA approved for opioid use disorder, acts as a peripheral nerve 
stimulator/modulator. Nerves potentially affected by the electrodes placed on and around the 
ear include the auriculotemporal branch of the Mandibular Nerve, the posterior auricular 
branch of the Facial Nerve, the Glossopharyngeal Nerve, and the auricular branch of the Vagus 
Nerve, as well as the peripheral occipital and greater auricular nerves. This stimulation is 
believed to provide analgesic effects through influence on various neurotransmitters, including 
serotonin, norepinephrine and GABA, and has resulted in 56-75% reduction of opioid 
requirements in major abdominal surgery (4).   
 
The device has an integrated 3 volt battery, with an impedance range of 1 to 10 kilo-ohms. It 
provides symmetrical, biphasic stimulation at a frequency of 0.125 Hz. Its package notes that it 
is contraindicated for patients with pacemakers, those with hemophilia (since the electrodes 
involve a micro-needle puncture), and psoriasis involving the ear. We would broaden this to 
include any patient with active anticoagulation, or any dermatologic condition involving the 
skin of the ear where the device would be placed.   
 
Study Hypothesis:  Use of the Bridge device will reduce opioid requirements (after resolution of 
block) by more than 33% on postoperative days 1 through 5. 

Primary Outcome: Cumulative Oral Opioid Use (expressed as Oral Morphine Equivalents) on 
Postoperative days 1 through 5. 
 
Secondary Outcomes: NRS pain scores recorded every four hours on postoperative days 0 to 4, 
                                         Oral opioid use on Individual Postoperative days 5 through 7 
                                        NRS pain scores recorded every 8 hours on postoperative days 4 to 7 
                                         Adverse effects related to opioids (nausea, dizziness, vomiting, itching) 
                                         Local adverse effects on ear related to use of bridge device (pain, etc) 
 
Setting: UPMC West Mifflin Ambulatory Surgery Center, West Mifflin, PA. Specifically with use 
in ambulatory rotator cuff repair patients. 
 
Subjects: We plan to enroll 15 patients in this observational, “proof of concept” study, in order 
to evaluate whether a 33% reduction in opioid use is possible over postoperative days 1 
through five (after resolution of block), as compared to historical controls. 
 
Procedures: Informed consent will be obtained, per IRB requirements. Standard anesthesia will 
be provided for rotator cuff repair for all patients. This includes single-shot bupivacaine 
interscalene nerve block with propofol sedation for the surgery itself, followed by application of 
the Bridge device in consented patients. Application of Bridge device occurs after surgery in 
recovery area. The ear is scrubbed with alcohol and electrodes placed in the required areas on 
or just in front of auricle.  The device is then activated in the PACU. Patients will fill out a "pain 
diary" at home to record oral opioid use and pain scores as noted above, for first seven days 
after surgery.  A study coordinator will call the patients on postoperative day 1, 3 and 7 to 
evaluate them. The device becomes inactive after 5 days and will be removed and discarded. At 
the end of 7 days, patients will fill out a Quality of Recovery survey, as well as a survey about 
the impact of the use of the device on their pain and recovery. 
 
Endpoints: These include the primary and secondary outcomes noted above. At the end of five 
days, the device will be removed by the patient and discarded. Any patient who develops pain 
or skin irritation (or other adverse reaction) from the Bridge device will be advised to remove it 
and their participation will be stopped at that time. 
 
Data Analysis: Descriptive statistics will be utilized, including comparison to historic controls. 
Mean pain values based on recorded NRS score for each postoperative day will be compared 
between groups. For the primary outcome, opioid ingestion over the entire interval of 
postoperative days 1 to 5 will be expressed as mean OME for each group, reported with 95% 
confidence interval. In pain scores, a difference of at least 1.7 on NRS scoring is considered to 
represent a meaningful clinical difference for shoulder surgery. 
 
 
1.    Abdallah FW Anesth Analg 2015;120:1114. 
2.    Hussain N. Anesthesiology 2021;134:147 
3.    Chelly JE. J Complement Integr Med 2021 doi:10.1515/jcim-2021-0208 

4.    Ilfeld BM Reg Anesth Pain Med 2022;47:581