Bridge Device for Surgical Pain for Rotator Cuff Surgery
- Conditions
- PainRotator Cuff Injuries
- Interventions
- Device: Bridge Percutaneous Nerve Field Stimulator
- Registration Number
- NCT06071884
- Lead Sponsor
- Steven Orebaugh
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bridge Percutaneous Nerve Field Stimulator Bridge Percutaneous Nerve Field Stimulator The case group (n = 15) will receive an activated Bridge device after surgery and continuing wearing the device until post-operative day (POD) 7.
- Primary Outcome Measures
Name Time Method Oral Opioid Use POD 4 Post-Operative Day 4 This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.
Oral Opioid Use POD 1 Post-Operative Day 1 This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.
Oral Opioid Use POD 2 Post-Operative Day 2 This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.
Oral Opioid Use POD 5 Post-Operative Day 5 This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.
Oral Opioid Use POD 3 Post-Operative Day 3 This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.
- Secondary Outcome Measures
Name Time Method Self-Reported Pain Scores POD 1 Post-Operative Day 1 Pain scores will be completed on a Numeric Rating Scale (NRS) of 0=no pain at all and 10=the most severe pain.
Self-Reported Pain Scores POD 4 Post-Operative Day 4 Pain scores will be completed on a Numeric Rating Scale (NRS) of 0=no pain at all and 10=the most severe pain.
Self-Reported Pain Scores POD 2 Post-Operative Day 2 Pain scores will be completed on a Numeric Rating Scale (NRS) of 0=no pain at all and 10=the most severe pain.
Local adverse events on ear related to device POD 1 Post-operative Day 1 Recorded as yes/no for adverse events related to the device such as pain or skin irritation
Self-Reported Pain Scores POD 3 Post-Operative Day 3 Pain scores will be completed on a Numeric Rating Scale (NRS) of 0=no pain at all and 10=the most severe pain.
Self-Reported Oral Opioid Use POD 7 Post-Operative Day 7 Collected through the subject diary and recorded as total dosage (mg) taken
Self-Reported Pain Scores POD 6 Post-Operative Day 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
Self-Reported Pain Scores POD 5 Post-Operative Day 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
Self-Reported Oral Opioid Use POD 6 Post-Operative Day 6 Collected through the subject diary and recorded as total dosage (mg) taken
Self-Reported Pain Scores POD 7 Post-Operative Day 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
Adverse events related to opioid POD 7 Post-Operative Day 7 Recorded as yes/no for adverse events related to opioids like nausea, vomiting, dizziness, and itching
Local adverse events on ear related to device POD 2 Post-operative Day 2 Recorded as yes/no for adverse events related to the device such as pain or skin irritation
Local adverse events on ear related to device POD 3 Post-operative Day 3 Recorded as yes/no for adverse events related to the device such as pain or skin irritation
Local adverse events on ear related to device POD 5 Post-operative Day 5 Recorded as yes/no for adverse events related to the device such as pain or skin irritation
Adverse events related to opioid POD 5 Post-Operative Day 5 Recorded as yes/no for adverse events related to opioids like nausea, vomiting, dizziness, and itching
Local adverse events on ear related to device POD 4 Post-operative Day 4 Recorded as yes/no for adverse events related to the device such as pain or skin irritation
Self-Reported Oral Opioid Use POD 5 Post-Operative Day 5 Collected through the subject diary and recorded as total dosage (mg) taken
Adverse events related to opioid POD 6 Post-Operative Day 6 Recorded as yes/no for adverse events related to opioids like nausea, vomiting, dizziness, and itching
Trial Locations
- Locations (1)
UPMC Outpatient Center
🇺🇸West Mifflin, Pennsylvania, United States