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

NCT04010266 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2024-02-14

Study results available
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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.

Conditions

  • Opioid Use
  • Arthropathy of Knee
  • Pain, Postoperative

Interventions

DEVICE

RelieVRx headset

RelieVRx is a virtual reality therapy intended as adjunctive treatment for acute surgical pain

DRUG

multi-modality pain management

combination of medications may be used such as a local anesthesia, ibuprofen, acetaminophen, gabapentin, ketamine, lidocaine, and opioids

Sponsors & Collaborators

  • Geisinger Clinic

    collaborator OTHER

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • AppliedVR Inc.

    lead INDUSTRY

Principal Investigators

  • Dr. Michael Suk · Geisinger Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2022-08-31
Completion
2023-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04010266 on ClinicalTrials.gov