A Randomized Controlled Trial of ZYNRELEF Versus Standard of Care for Pain Management Following Unilateral Total Knee Arthroplasty

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
Doctors Hospital
RECRUITING
Miami
Contact Information
Primary
Yvette Hernandez
yvettesal@baptisthealth.net
786-308-2217
Backup
Chukwuemeka Osondu
emekao@baptisthealth.net
786-308-2011
Time Frame
Start Date: 2023-03-09
Estimated Completion Date: 2027-12
Participants
Target number of participants: 242
Treatments
Experimental: Intervention
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.
No_intervention: Standard-of-care
Usual standard of care procedure for knee replacement and pain management before, during and immediately following surgery.
Sponsors
Leads: Baptist Health South Florida

This content was sourced from clinicaltrials.gov