Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty

Phase 4

Completed

• Conditions: Total Knee Arthroplasty
• Interventions: Drug: ropivacaine , epinephrine , ketorolac diluted in sodium chloride; Drug: HTX-011

• Registration Number: NCT05188053
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this study is to compare an FDA-approved medication for post-operative pain control (HTX-011) to the standard of care institutional practice for periarticular analgesia after primary total knee arthroplasty (weight based dosing of Ropivacaine, epinephrine and ketorolac diluted with saline). We are doing this research study to find out if this new medication provides superior pain control within 72 hours following surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-27
• Study First Submitted QC: 2022-01-11
• Study First Posted: 2022-01-12
• Study Start: 2022-03-11
• Primary Completion: 2024-04-18
• Study Completion: 2024-04-18
• Results First Submitted: 2025-03-07
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-11
• Last Update Submitted: 2025-04-11
• Results First Posted: 2025-04-27
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

Inclusion Criteria

• ASA classification I to III, older than or equal to 18 years old.
• Presenting for primary total knee replacement for degenerative joint disease.
• Patient capable of providing their own informed consent.

Exclusion Criteria

• Vulnerable study populations including prisoners.
• Patients with a contralateral total knee arthroplasty < 2 years prior to the index procedure.
• Compromised health barring them from proceeding with surgery including acute or chronic kidney injury identified pre-operative.
• Patients unable to provide their own informed consent.
• Pregnancy.
• Patients with documented chronic pain syndromes.
• Patients with a history of prolonged daily opioids (more than 1 month) with an oral morphine equivalent of greater than 5mg/day.
• BMI > 45 kg/m^2.
• Allergies to any component of the study medications, including specific history of type 1 hypersensitivities to any NSAID.
• Patients with impaired cognitive function.
• Major systemic illnesses such as severe renal (estimated glomerular filtration rate less than 50ml/min), coronary artery disease requiring a bypass graft (CABG), other cardiac problems including congestive heart failure (CHF New York Heart Association class III to IV), or severe hepatic disorders defined as current or past diagnosis of acute/subacute liver necrosis, acute hepatic failure, chronic liver disease, liver abscess, hepatic coma, hepatorenal syndrome and other disorders of the liver.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Block Control Group	ropivacaine , epinephrine , ketorolac diluted in sodium chloride	Subjects undergoing a total knee arthroplasty will receive standard of care arthroplasty block for perioperative analgesia
HTX-011 Treatment Group	HTX-011	Subjects undergoing a total knee arthroplasty will receive HTX-011 (Zynrelef) for perioperative analgesia

Primary Outcome Measures

Name	Time	Method
Pain Control at 72 Hours Postoperatively	72-hours postoperatively after total knee arthroplasty	Area Under the Curve (AUC) of the graph for mean Numerical Rated Score (NRS) for pain (0-10) over time (0-72 hours) / NRS AUC 0-72. Pain scores were collected by patient self-report 15 times over the 72 hours after surgery, and averaged amongst the patients for each study arm.; Lower values represent better pain control based on lower mean 0-10 pain scores over the 72 hour period after surgery. The minimum value is 0, meaning patients reported 0 pain on a 0-10 scale at all 15 time points within 72 hours. The maximum value would be 720, meaning patients reported a 10 for pain on a 0-10 scale at all 15 time points within 72 hours.

Secondary Outcome Measures

Name	Time	Method
Opioid Consumption 72 Hours Postoperatively	72-hours postoperative total knee arthroplasty	Total postoperative opioid consumption standardized into morphine milligram equivalents (MMEs)
Opioid Consumption 48 Hours Postoperatively	48 hours postoperative total knee arthroplasty	Total postoperative opioid consumption standardized into morphine milligram equivalents (MMEs)
Pain Control at 48 Hours Postoperatively	48-hours postoperative total knee arthroplasty	Area Under the Curve (AUC) of the graph for mean Numerical Rated Score (NRS) for pain (0-10) over time (0-48 hours) / NRS AUC 0-48. Pain scores were collected by patient self-report 11 times over the 48 hours after surgery, and averaged amongst the patients for each study arm.; Lower values represent better pain control based on lower mean 0-10 pain scores over the 48 hour period after surgery. The minimum value is 0, meaning patients reported 0 pain on a 0-10 scale at all 11 time points within 48 hours. The maximum value would be 480, meaning patients reported a 10 for pain on a 0-10 scale at all 11 time points within 48 hours

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States