Clinical trial NCT06071884: Bridge Device for Surgical Pain for Rotator Cuff Surgery
Official title: Evaluation of Bridge Device in Pain Management for Outpatient Rotator Cuff Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Rotator Cuff Injuries
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Masimo Corporation
First posted: 2023-10-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Oral Opioid Use POD 1
timeFrame: Post-Operative Day 1
measure: Oral Opioid Use POD 2
timeFrame: Post-Operative Day 2
measure: Oral Opioid Use POD 3
timeFrame: Post-Operative Day 3
measure: Oral Opioid Use POD 4
timeFrame: Post-Operative Day 4
measure: Oral Opioid Use POD 5
timeFrame: Post-Operative Day 5
Secondary outcomes:
measure: Self-Reported Pain Scores POD 1
timeFrame: Post-Operative Day 1
measure: Self-Reported Pain Scores POD 2
timeFrame: Post-Operative Day 2
measure: Self-Reported Pain Scores POD 3
timeFrame: Post-Operative Day 3
measure: Self-Reported Pain Scores POD 4
timeFrame: Post-Operative Day 4
measure: Self-Reported Pain Scores POD 5
timeFrame: Post-Operative Day 5
measure: Self-Reported Oral Opioid Use POD 5
timeFrame: Post-Operative Day 5
measure: Self-Reported Oral Opioid Use POD 6
timeFrame: Post-Operative Day 6
measure: Self-Reported Oral Opioid Use POD 7
timeFrame: Post-Operative Day 7
measure: Self-Reported Pain Scores POD 5
timeFrame: Post-Operative Day 5
measure: Self-Reported Pain Scores POD 6
timeFrame: Post-Operative Day 6
measure: Self-Reported Pain Scores POD 7
timeFrame: Post-Operative Day 7
measure: Adverse events related to opioid POD 5
timeFrame: Post-Operative Day 5
measure: Adverse events related to opioid POD 6
timeFrame: Post-Operative Day 6
measure: Adverse events related to opioid POD 7
timeFrame: Post-Operative Day 7
measure: Local adverse events on ear related to device POD 1
timeFrame: Post-operative Day 1
measure: Local adverse events on ear related to device POD 2
timeFrame: Post-operative Day 2
measure: Local adverse events on ear related to device POD 3
timeFrame: Post-operative Day 3
measure: Local adverse events on ear related to device POD 4
timeFrame: Post-operative Day 4
measure: Local adverse events on ear related to device POD 5
timeFrame: Post-operative Day 5
Other outcomes:
Locations:
city: West Mifflin
country: United States
facility: UPMC Outpatient Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Steven L Orebaugh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Amy Monroe, MPH, MBA
role: STUDY_DIRECTOR
References: