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ZYNRELEF for Pain Management in Total Knee Arthroplasty

Primary Purpose

Post Operative Pain, Osteoarthritis, Knee

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine-Meloxicam 400 Mg-12 Mg/14 mL Injectable Solution, Extended Release
Sponsored by
Baptist Health South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring Knee Arthroplasty, Postoperative pain management

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult patients undergoing primary unilateral total knee arthroplasty [Current Procedural Terminology Code: 27447] Patients with a diagnosis of primary osteoarthritis [ICD-10 codes: M17.0, M17.10, M17.11, M17.12] Varus deformity less than 10 degrees Flexion contracture less than 10 degrees Age 35 - 70 years old BMI < 40 Patients who are discharged on the same day after the unilateral total knee arthroplasty procedure Exclusion Criteria: Inflammatory arthritis Post-traumatic arthritis Valgus deformity Severe varus (> 10 degrees) Severe flexion contracture (> 10 degrees) Overnight or longer hospital stay after surgery Prior surgery on affected knee other than knee arthroscopy for meniscal or cartilage debridement/repair Creatinine > 1.2 Chronic Kidney Disease (CKD) stage 3, 4, 5 or end stage renal disease Uncontrolled Diabetes mellitus (Glycated Hemoglobin > 8.0%) Current liver disease Personal history of depression or anxiety disorder Personal history of Deep Venous Thrombosis (DVT) or Pulmonary Embolism (PE) Narcotic or tramadol use within 2 weeks of the planned procedure Allergy to aspirin, NSAIDS, oxycodone, Tylenol, local anesthetics Walking aid for anything other than the operative joint Contraindication for use of the study drug (as specified by the manufacturer): Known hypersensitivity to local amide anesthetics, NSAIDs or study drug components History of asthma, urticaria or other allergic-type reactions to aspirin or other NSAIDs Patients taking the following medications: Amitriptyline Nortriptyline Gabapentin Pregabalin Duloxetine (SNRI) Des-Venlafaxine (SNRI) Cyclobenzaprine Baclofen Pregnant or lactating females Patients unable to provide informed consent Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures

Sites / Locations

  • Doctors HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Standard-of-care

Arm Description

In addition to the standard-of-care arm description, single administration of Bupivacaine-Meloxicam 400 Mg-12 Mg/14 mL Injectable Solution, Extended Release in the surgical site before complete wound closure.

Usual standard of care procedure for knee replacement and pain management before, during and immediately following surgery.

Outcomes

Primary Outcome Measures

Total opioid analgesic consumption
Amount of opioid analgesic consumed in the time frame calculated as Morphine Milligram Equivalent (MME).
Change in pain assessment scores
Pain assessment scores using the pain Numeric Rating Scale for pain (NRS). The NRS scale is measured on a scale of 0 - 10, where 0 is no pain and 10 is the most severe pain.

Secondary Outcome Measures

Incidence of major complications
Number of procedure-related adverse events and medication-related adverse events.

Full Information

First Posted
November 11, 2022
Last Updated
March 16, 2023
Sponsor
Baptist Health South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT05644496
Brief Title
ZYNRELEF for Pain Management in Total Knee Arthroplasty
Official Title
A Randomized Controlled Trial of ZYNRELEF Versus Standard of Care for Pain Management Following Unilateral Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2023 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baptist Health South Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this randomized controlled trial is to compare opioid medication consumption after surgery for patients who have a total knee replacement. The main questions it aims to answer are: How well does the study drug control pain in the days after surgery? Does the study drug reduce the amount of opioid analgesic consumed after surgery? Participants in the study group will undergo a total knee replacement as planned with their surgeon. In addition, be given the study drug, Zynrelef (combination of bupivacaine and meloxicam). Researchers will compare the above to a control group who will have a total knee replace only according to usual standards to see if there are any differences in the amount of a type of pain medication (opioid analgesic) consumed in the days following surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Osteoarthritis, Knee
Keywords
Knee Arthroplasty, Postoperative pain management

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
242 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
In addition to the standard-of-care arm description, single administration of Bupivacaine-Meloxicam 400 Mg-12 Mg/14 mL Injectable Solution, Extended Release in the surgical site before complete wound closure.
Arm Title
Standard-of-care
Arm Type
No Intervention
Arm Description
Usual standard of care procedure for knee replacement and pain management before, during and immediately following surgery.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine-Meloxicam 400 Mg-12 Mg/14 mL Injectable Solution, Extended Release
Other Intervention Name(s)
Zynrelef
Intervention Description
Instillation of the drug into the knee joint capsule and surrounding tissues after placing the knee prosthesis and before close of the surgical wound
Primary Outcome Measure Information:
Title
Total opioid analgesic consumption
Description
Amount of opioid analgesic consumed in the time frame calculated as Morphine Milligram Equivalent (MME).
Time Frame
5 days following surgical procedure
Title
Change in pain assessment scores
Description
Pain assessment scores using the pain Numeric Rating Scale for pain (NRS). The NRS scale is measured on a scale of 0 - 10, where 0 is no pain and 10 is the most severe pain.
Time Frame
Baseline and every 24 hours for 120 hours following surgical procedure
Secondary Outcome Measure Information:
Title
Incidence of major complications
Description
Number of procedure-related adverse events and medication-related adverse events.
Time Frame
42 days following surgical procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients undergoing primary unilateral total knee arthroplasty [Current Procedural Terminology Code: 27447] Patients with a diagnosis of primary osteoarthritis [ICD-10 codes: M17.0, M17.10, M17.11, M17.12] Varus deformity less than 10 degrees Flexion contracture less than 10 degrees Age 35 - 70 years old BMI < 40 Patients who are discharged on the same day after the unilateral total knee arthroplasty procedure Exclusion Criteria: Inflammatory arthritis Post-traumatic arthritis Valgus deformity Severe varus (> 10 degrees) Severe flexion contracture (> 10 degrees) Overnight or longer hospital stay after surgery Prior surgery on affected knee other than knee arthroscopy for meniscal or cartilage debridement/repair Creatinine > 1.2 Chronic Kidney Disease (CKD) stage 3, 4, 5 or end stage renal disease Uncontrolled Diabetes mellitus (Glycated Hemoglobin > 8.0%) Current liver disease Personal history of depression or anxiety disorder Personal history of Deep Venous Thrombosis (DVT) or Pulmonary Embolism (PE) Narcotic or tramadol use within 2 weeks of the planned procedure Allergy to aspirin, NSAIDS, oxycodone, Tylenol, local anesthetics Walking aid for anything other than the operative joint Contraindication for use of the study drug (as specified by the manufacturer): Known hypersensitivity to local amide anesthetics, NSAIDs or study drug components History of asthma, urticaria or other allergic-type reactions to aspirin or other NSAIDs Patients taking the following medications: Amitriptyline Nortriptyline Gabapentin Pregabalin Duloxetine (SNRI) Des-Venlafaxine (SNRI) Cyclobenzaprine Baclofen Pregnant or lactating females Patients unable to provide informed consent Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yvette Hernandez
Phone
786-308-2217
Email
yvettesal@baptisthealth.net
First Name & Middle Initial & Last Name or Official Title & Degree
Chukwuemeka Osondu
Phone
786-308-2011
Email
emekao@baptisthealth.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan C Suarez, MD
Organizational Affiliation
Baptist Health South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Doctors Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yvette Hernandez
Email
yvettesal@baptisthealth.net
First Name & Middle Initial & Last Name & Degree
Chukwuemeka Osondu, MD
Email
emekao@baptisthealth.net
First Name & Middle Initial & Last Name & Degree
Juan C Suarez, MD
First Name & Middle Initial & Last Name & Degree
Charles M Lawrie, MD
First Name & Middle Initial & Last Name & Degree
Alexander van der Ven, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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ZYNRELEF for Pain Management in Total Knee Arthroplasty

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