Bridge Device for Surgical Pain for Rotator Cuff Surgery

Steven Orebaugh

Status: Completed

Conditions: Pain; Rotator Cuff Injuries

Treatments: Device: Bridge Percutaneous Nerve Field Stimulator

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06071884

STUDY23030139

Details and patient eligibility

About

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.

Full 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.

*Prior to study enrollment, the outcome measure timepoints were updated to postoperative days (POD) 1, 3, 5, and 7. This was largely due to pain trajectories in surgical populations often follow a predictable, nonlinear course, with meaningful fluctuations most apparent on alternating days rather than daily increments. By assessing the outcome measures on POD 1, 3, 5, and 7, the revised scheduled timepoints continues to capture initial peak (POD 1), early recovery phase (POD3), the late recovery phase (POD 5), and the resolution/transition phase (POD 7) regarding pain trajectories.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Bridge Percutaneous Nerve Field Stimulator

Experimental group

Description:

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

Treatment:

Device: Bridge Percutaneous Nerve Field Stimulator

Historical Control

No Intervention group

Description:

Historical Controls (n=27) who previously had arthroscopic ambulatory rotator cuff surgery, all other factors are the same as the intervention group (multimodal analgesia, etc.)