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

Masimo Corporation5 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Pain, Postoperative

Interventions

Bridge deviceDEVICE

Bridge is a percutaneous nerve field stimulation device which uses alternating currents of stimulation over a large field and with higher voltage in order to influence central pain areas.

Sham deviceDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Change in Total Opioid Consumption Between Active and Sham Arms.

The sample size is well below the threshold needed to reliably assess outcomes and perform statistical comparisons. As a result, we have provided the raw data for comparison of opioid consumption between the two groups.

Time frame: Day of surgery to Day 5 (120 hours) post-op

Secondary Outcomes

Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale.

Pain scores using a numerical scale will be collected at rest and movement and will be obtained prior to surgery, in the recovery room, prior to leaving the recovery room, every 6 hours during the first 24 hrs, and at 48, 72, 96 and 120 hours post-operatively. Subjects will use a 0-10 numeric scale (0 indicating no pain and 10 indicating extreme pain).

Time frame: Day of surgery to Day 5 (120 hours) post-op

Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale.

Postoperative nausea and vomiting will be evaluated from immediately after surgery through postoperative day 5, using a 0-10 scale (0 indicating no nausea and 10 indicating extreme nausea).

Time frame: Day of surgery to Day 5 (120 hours) post-op

Change in Functional Recovery Between Active and Sham Arms Assessed Using the Timed Up and Go (TUG) Assessment Collected on Post-Op Day 30

Functional recovery will be assessed daily from day of surgery to post-op day 5, using the Timed Up and Go assessment to assess mobility.

Time frame: Day of surgery to post-operative day 30.

Change in Functional Recovery Between Active and Sham Arms Assessed Using the 12-Item Short Form Survey (SF-12) Collected on Post-Op Day 30

Subjects will also complete the 12-Item Short Form Survey (SF-12) on Post-Op day 30 to evaluate quality of recovery.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.