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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am having a knee replacement surgery on one knee.
Select...
I received spinal anesthesia for my total knee replacement.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Opioid consumption
Postoperative pain
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
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Who is running the clinical trial?
Rothman Institute OrthopaedicsLead Sponsor
121 Previous Clinical Trials
21,518 Total Patients Enrolled
3 Trials studying Postoperative Pain
523 Patients Enrolled for Postoperative Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have been diagnosed with chronic pain or complex regional pain syndrome.You cannot take NSAIDs for medical reasons.You are allergic to NSAIDs or bupivacaine.I am experiencing severe pain from other health conditions.I am on long-term blood thinners, preventing me from taking NSAIDs.I have been using more than 20 mg/day of opioids for the last 3 months.I am having a knee replacement surgery on one knee.I am scheduled for a knee replacement surgery.I am having both knees replaced at the same time.I can think clearly enough to answer questions for a study.I am having partial knee replacement surgery.I am having surgery to replace the kneecap area of my knee.I received spinal anesthesia for my total knee replacement.
Research Study Groups:
This trial has the following groups:- Group 1: primary total knee replacement + Zynrelef
- Group 2: primary total knee replacement + adductor canal block (ACB)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still available for this research endeavor?
"According to clinicaltrials.gov this study is no longer recruiting participants, its last update being on March 1st 2023. Although the trial itself has stopped enrolling patients, there are still 459 trials actively looking for volunteers at present."
Answered by AI
Has the amalgamation of primary total knee replacement and Zynrelef been validated by the FDA?
"As this is a Phase 3 trial with existing data backing its efficacy and safety, we at Power have given primary total knee replacement + Zynrelef the highest possible accreditation of 3."
Answered by AI
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