Feasibility of Bridge for Post-Operative Pain Management in Hip Arthroplasty

Masimo

Status: Terminated

Conditions: Pain, Postoperative

Treatments: Device: Sham device; Device: Bridge device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05017701

CHEL0001

Details and patient eligibility

About

The aim of this research study is to gather data regarding the feasibility of the Bridge system for the management of pain following total hip arthroplasty (THA).

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is 18 years of age or older
• Subject scheduled for elective primary unilateral total hip arthroplasty (THA)
• Subject opioid use is less than 60 milligram morphine equivalent for the last 30 days
• Subject has given written informed consent to participate in the study

Exclusion criteria

• Subjects who are pregnant or breastfeeding
• Subjects with cardiac pacemakers or other implanted devices (e.g. vagal nerve simulators), hemophilia or psoriasis vulgaris
• Subjects with a history of active depression, anxiety or catastrophizing
• Subjects with active alcoholism or drug abuse
• Subjects with severe chronic pain condition that requires daily preoperative opioid dependence
• Subjects deemed not suitable for the study at the discretion of the principal investigator
• Subjects who are concurrently participating in any other research study

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5 participants in 2 patient groups

Bridge device

Experimental group

Description:

The active Bridge device delivers electrical stimulation to the cranial and occipital nerves.

Treatment:

Device: Bridge device

Sham device

Sham Comparator group

Description:

The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses

Treatment:

Device: Sham device