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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 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06071884
Study type Interventional
Source University of Pittsburgh
Contact Carly Riedmann, BS
Phone 4126234147
Email riedmannca@upmc.edu
Status Not yet recruiting
Phase N/A
Start date July 31, 2024
Completion date December 31, 2025
View Details
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