Bridge Device for Surgical Pain for Rotator Cuff Surgery

Pain Clinical Trial

Official title:

Evaluation of Bridge Device in Pain Management for Outpatient Rotator Cuff Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06071884
• Other study ID #: STUDY23030139
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 31, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: University of Pittsburgh
• Contact: Carly Riedmann, BS
• Phone: 4126234147
• Email: riedmannca[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: December 31, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Rotator Cuff Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	UPMC Outpatient Center	West Mifflin	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Steven Orebaugh	Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral Opioid Use POD 1	This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.	Post-Operative Day 1
Primary	Oral Opioid Use POD 2	This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.	Post-Operative Day 2
Primary	Oral Opioid Use POD 3	This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.	Post-Operative Day 3
Primary	Oral Opioid Use POD 4	This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.	Post-Operative Day 4
Primary	Oral Opioid Use POD 5	This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.	Post-Operative Day 5
Secondary	Self-Reported Pain Scores POD 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
Secondary	Self-Reported Pain Scores POD 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
Secondary	Self-Reported Pain Scores POD 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
Secondary	Self-Reported Pain Scores POD 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
Secondary	Self-Reported Pain Scores POD 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
Secondary	Self-Reported Oral Opioid Use POD 5	Collected through the subject diary and recorded as total dosage (mg) taken	Post-Operative Day 5
Secondary	Self-Reported Oral Opioid Use POD 6	Collected through the subject diary and recorded as total dosage (mg) taken	Post-Operative Day 6
Secondary	Self-Reported Oral Opioid Use POD 7	Collected through the subject diary and recorded as total dosage (mg) taken	Post-Operative Day 7
Secondary	Self-Reported Pain Scores POD 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
Secondary	Self-Reported Pain Scores POD 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
Secondary	Self-Reported Pain Scores POD 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
Secondary	Adverse events related to opioid POD 5	Recorded as yes/no for adverse events related to opioids like nausea, vomiting, dizziness, and itching	Post-Operative Day 5
Secondary	Adverse events related to opioid POD 6	Recorded as yes/no for adverse events related to opioids like nausea, vomiting, dizziness, and itching	Post-Operative Day 6
Secondary	Adverse events related to opioid POD 7	Recorded as yes/no for adverse events related to opioids like nausea, vomiting, dizziness, and itching	Post-Operative Day 7
Secondary	Local adverse events on ear related to device POD 1	Recorded as yes/no for adverse events related to the device such as pain or skin irritation	Post-operative Day 1
Secondary	Local adverse events on ear related to device POD 2	Recorded as yes/no for adverse events related to the device such as pain or skin irritation	Post-operative Day 2
Secondary	Local adverse events on ear related to device POD 3	Recorded as yes/no for adverse events related to the device such as pain or skin irritation	Post-operative Day 3
Secondary	Local adverse events on ear related to device POD 4	Recorded as yes/no for adverse events related to the device such as pain or skin irritation	Post-operative Day 4
Secondary	Local adverse events on ear related to device POD 5	Recorded as yes/no for adverse events related to the device such as pain or skin irritation	Post-operative Day 5