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Neurostimulation an Adjuvant Postoperative Analgesic in Total Knee Replacement (TKR) Surgeries

NCT05416294 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2022-07-29

No results posted yet for this study

Summary

To study and evaluate the effect of using the Primary Relief PENS treatment as adjuvant analgesia for reducing pain in total knee replacement (TKR) patients.

Conditions

  • Arthroplasty, Knee Replacement

Interventions

DEVICE

Primary Relief

The group will receive PENS treatment using Primary Relief in addition to the multimodal analgesia (morphine, ketorolac, methyl, prednisolone, adrenaline) including the periarticular infiltration of local anaesthetic and/or femoral or epidural catheter for postoperative pain management (bupivacaine, ropivacaine).

DEVICE

Inactive Primary Relief

The group will receive a sham device with multimodal analgesia (morphine, ketorolac, methyl, prednisolone, adrenaline), including the periarticular infiltration of local anaesthetic and/or femoral or epidural catheter for postoperative pain management (bupivacaine, ropivacaine).

Sponsors & Collaborators

  • DyAnsys, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-15
Primary Completion
2022-09-15
Completion
2022-09-30

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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 NCT05416294 on ClinicalTrials.gov