drugset / Trial / NCT04010266
RelieVRx for Total Knee Arthroplasty (TKA) for the Reduction of Acute Postoperative Pain and Opioid Use
Completed
63 enrolled
AppliedVR Inc.
Geisinger Clinic · collabNational Institute on Drug Abuse (NIDA) · collab
RandomizedParallel-groupSingle-blindSupportive care
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.
Timeline
- Start
- 2021-03-01
- Primary completion
- 2022-08-31
- Completion
- 2023-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Acetaminophen | Small molecule | — | — |
| Background | Gabapentin | Small molecule | — | — |
| Background | Ibuprofen | Small molecule | — | — |
| Background | Ketamine | Small molecule | — | — |
| Background | Lidocaine | Other / unclassified | — | — |