Bridge Device for Surgical Pain for Rotator Cuff Surgery

April 1, 2024 updated by: Steven Orebaugh

Evaluation of Bridge Device in Pain Management for Outpatient 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Bridge Percutaneous Nerve Field Stimulator
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.
Other Names:
  • NSS-2 BRIDGE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral Opioid Use POD 1
Time Frame: Post-Operative Day 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
Time Frame: Post-Operative Day 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
Time Frame: Post-Operative Day 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
Time Frame: Post-Operative Day 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
Time Frame: Post-Operative Day 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
Time Frame: 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.
Post-Operative Day 1
Self-Reported Pain Scores POD 2
Time Frame: 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.
Post-Operative Day 2
Self-Reported Pain Scores POD 3
Time Frame: 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.
Post-Operative Day 3
Self-Reported Pain Scores POD 4
Time Frame: 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.
Post-Operative Day 4
Self-Reported Pain Scores POD 5
Time Frame: Post-Operative Day 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
Time Frame: Post-Operative Day 5
Collected through the subject diary and recorded as total dosage (mg) taken
Post-Operative Day 5
Self-Reported Oral Opioid Use POD 6
Time Frame: Post-Operative Day 6
Collected through the subject diary and recorded as total dosage (mg) taken
Post-Operative Day 6
Self-Reported Oral Opioid Use POD 7
Time Frame: Post-Operative Day 7
Collected through the subject diary and recorded as total dosage (mg) taken
Post-Operative Day 7
Self-Reported Pain Scores POD 5
Time Frame: 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
Post-Operative Day 5
Self-Reported Pain Scores POD 6
Time Frame: 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
Post-Operative Day 6
Self-Reported Pain Scores POD 7
Time Frame: 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
Post-Operative Day 7
Adverse events related to opioid POD 5
Time Frame: Post-Operative Day 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
Time Frame: Post-Operative Day 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
Time Frame: Post-Operative Day 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
Time Frame: Post-operative Day 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
Time Frame: Post-operative Day 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
Time Frame: Post-operative Day 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
Time Frame: Post-operative Day 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
Time Frame: Post-operative Day 5
Recorded as yes/no for adverse events related to the device such as pain or skin irritation
Post-operative Day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Steven Orebaugh

Collaborators

Masimo Corporation

Investigators

  • Study Director: Amy Monroe, MPH, MBA, University of Pittsburgh
  • Principal Investigator: Steven L Orebaugh, MD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 30, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

September 24, 2023

First Submitted That Met QC Criteria

October 3, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY23030139

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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