RelieVRx for Total Knee Arthroplasty (TKA) for the Reduction of Acute Postoperative Pain and Opioid Use

Ketamine

Brief Summary

This is a single-center, prospective, randomized, controlled study of the appliedVR RelieVRx headset in subjects undergoing Total Knee Arthroplasty (TKA). This study will evaluate two primary endpoints - effectiveness of a single use of RelieVRx in the reduction of acute postoperative pain by 20%; and overall effectiveness of RelieVRx as an opioid-sparing intervention, where opioid consumption is reduced by at least 20% over a 90-day postoperative period in the interventional, standard of care (SOC) plus RelieVRx group compared to the control, SOC group.

Intervention / Treatment

  • Device: RelieVRx headset
  • Drug: multi-modality pain management

Condition or Disease

  • Opioid Use
  • Arthropathy of Knee
  • Pain, Postoperative

Phase

Study Design

Study type: Interventional
Status: Not yet recruiting
Study results: No Results Available
Age: 18 Years and older   (Adult, Older Adult)
Enrollment: 100 ()
Funded by: Industry|Other

Masking

Clinical Trial Dates

Start date: Aug 01, 2020
Primary Completion: Feb 01, 2022
Completion Date: Feb 01, 2022
Study First Posted: Jul 08, 2019
Results First Posted: Aug 31, 2020
Last Updated: Jul 15, 2020

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Location

Danville, Pennsylvania, USA
Wilkes-Barre, Pennsylvania, USA

This is a single-center, prospective, randomized, controlled study of the appliedVR RelieVRx headset in subjects undergoing Total Knee Arthroplasty (TKA). Patients will be randomized to one of the two groups after study enrollment, and patients in the test arm will be educated about the device preoperatively to facilitate its use in the acute post-operative period. The goals of VR will be presented in the context of an alternate method of pain control to opioids. This study will evaluate two primary endpoints - effectiveness of a single use of RelieVRx in the reduction of acute postoperative pain by 20%; and overall effectiveness of RelieVRx as an opioid-sparing intervention, where opioid consumption is reduced by at least 20% over a 90-day postoperative period in the interventional, standard of care (SOC) plus RelieVRx group compared to the control, SOC group.

Eligibility Criteria

Sex: All
Minimum Age: 18

More Details

NCT Number: NCT04010266
Other IDs: 2019-0388
Study URL: https://ClinicalTrials.gov/show/NCT04010266
Last updated: Jan 27, 2021