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ioveraº for Post Operative Pain Management

N/A
Waitlist Available
Research Sponsored by Pacira CryoTech, Inc., a wholly owned subsidiary of Pacira BioSciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 15 to day 90
Awards & highlights

Study Summary

This trial is testing whether freezing the nerves around the knee before surgery can help with pain control after surgery, compared to not freezing the nerves.

Eligible Conditions
  • Post Operative Pain Management

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 15 to day 90
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 15 to day 90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
NRS "worst pain" intensity scores from first pain assessment post-TKA (Day 1) to Day 30.
Secondary outcome measures
Acute postoperative sleep quality by NRS daily through the first 7 days post TKA
Change of KOOS scores (English version LK 1.0) from TKA Pre-Surgery visit to Day 30 visit post-TKA
Change of KOOS scores from screening visit to each of the following visits: TKA Pre-Surgery, Day 15, Day 30, Day 42, and Day 90
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Superficial Genicular NervesExperimental Treatment1 Intervention
Subjects will receive iovera° cryoneurolysis treatment of superficial genicular nerves (anterior femoral cutaneous nerve [AFCN] and infrapatellar branches of the saphenous nerve [ISN]) of the target knee
Group II: Sham ComparatorPlacebo Group1 Intervention
Subjects will receive sham iovera° treatment of superficial genicular nerves (AFCN and ISN) of the target knee

Find a Location

Who is running the clinical trial?

Pacira CryoTech, Inc., a wholly owned subsidiary of Pacira BioSciences, Inc.Lead Sponsor
19 Previous Clinical Trials
1,343 Total Patients Enrolled
Pacira Pharmaceuticals, IncLead Sponsor
136 Previous Clinical Trials
13,954 Total Patients Enrolled
6 Trials studying Post Operative Pain Management
349 Patients Enrolled for Post Operative Pain Management
Gary Nevins, DCStudy DirectorPacira Pharmaceuticals, Inc
1 Previous Clinical Trials
65 Total Patients Enrolled
1 Trials studying Post Operative Pain Management
65 Patients Enrolled for Post Operative Pain Management

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate Iovera®° in Adult Patients Undergoing Total Knee Arthroplasty
2020. "Study to Evaluate Iovera®° in Adult Patients Undergoing Total Knee Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04191031.
~18 spots leftby Apr 2025
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