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Local Anesthetic

Zynrelef + Bupivacaine for Postoperative Pain After Knee Replacement

Phase 3
Waitlist Available
Research Sponsored by Rothman Institute Orthopaedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing primary unilateral TKA
Patients receiving spinal anesthesia during primary TKA
Must not have
Patients undergoing bilateral simultaneous TKA
Patients undergoing conversion TKA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial studied the use of MMA to reduce opioid use after TKA, finding it decreased opioid use significantly with no adverse effects.

Who is the study for?
This trial is for adults over 18 who are having a primary total knee replacement (TKA) and will receive spinal anesthesia. They must be able to fill out questionnaires and not have allergies to NSAIDs or bupivacaine, no chronic pain syndromes, not on long-term anticoagulants or opioids, and not undergoing other types of knee surgeries.
What is being tested?
The study tests Zynrelef, a combination of Bupivacaine and Meloxicam designed for extended pain relief after TKA against traditional Bupivacaine. It aims to reduce the need for opioids by using multimodal analgesia techniques in postoperative care.
What are the potential side effects?
Possible side effects include reactions at the injection site, potential allergic responses if sensitive to ingredients, gastrointestinal issues due to NSAID content like meloxicam in Zynrelef, and typical local anesthetic risks such as numbness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am having a knee replacement surgery on one knee.
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I received spinal anesthesia for my total knee replacement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am having both knees replaced at the same time.
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I am scheduled for a knee replacement surgery.
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I am having partial knee replacement surgery.
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I am having surgery to replace the kneecap area of my knee.
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I am on long-term blood thinners, preventing me from taking NSAIDs.
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I have been diagnosed with chronic pain or complex regional pain syndrome.
Select...
I have been using more than 20 mg/day of opioids for the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Opioid consumption
Postoperative pain

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: primary total knee replacement + ZynrelefExperimental Treatment2 Interventions
Patients undergoing primary total knee replacement with Extended Relief Bupivacaine and Meloxicam (Zynrelef)
Group II: primary total knee replacement + adductor canal block (ACB)Active Control2 Interventions
Patients undergoing primary total knee replacement with routine adductor canal block

Find a Location

Who is running the clinical trial?

Rothman Institute OrthopaedicsLead Sponsor
126 Previous Clinical Trials
22,524 Total Patients Enrolled
8 Trials studying Infections
1,433 Patients Enrolled for Infections

Media Library

Primary Total Knee Replacement (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05751421 — Phase 3
Infections Research Study Groups: primary total knee replacement + Zynrelef, primary total knee replacement + adductor canal block (ACB)
Infections Clinical Trial 2023: Primary Total Knee Replacement Highlights & Side Effects. Trial Name: NCT05751421 — Phase 3
Primary Total Knee Replacement (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05751421 — Phase 3
~22 spots leftby Dec 2025
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