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

NCT05188053 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 21-010044
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Pain Control at 72 Hours Postoperatively

  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.

  72-hours postoperatively after total knee arthroplasty

Secondary Outcomes (3)

• Pain Control at 48 Hours Postoperatively

  48-hours postoperative total knee arthroplasty

• Opioid Consumption 72 Hours Postoperatively

  72-hours postoperative total knee arthroplasty

• Opioid Consumption 48 Hours Postoperatively

  48 hours postoperative total knee arthroplasty

Study Arms (2)

HTX-011 Treatment Group

EXPERIMENTAL

Subjects undergoing a total knee arthroplasty will receive HTX-011 (Zynrelef) for perioperative analgesia

Drug: HTX-011

Standard Block Control Group

ACTIVE COMPARATOR

Subjects undergoing a total knee arthroplasty will receive standard of care arthroplasty block for perioperative analgesia

Drug: ropivacaine , epinephrine , ketorolac diluted in sodium chloride

Interventions

HTX-011 DRUG

Single dose administration periarticular 400mg bupivacaine and 12mg meloxicam extended release solution

Also known as: Zynrelef

HTX-011 Treatment Group

ropivacaine , epinephrine , ketorolac diluted in sodium chloride DRUG

Single dose administration in 100cc of standard formulation, there is 225mg of ropivacaine 5mg/mL, 0.6mg epinephrine 1mg/mL, 30mg ketorolac 30mg/mL diluted in sodium chloride

Also known as: Mayo Clinic standard arthroplasty block

Standard Block Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

bupivacaine-meloxicam drug combination; Ropivacaine; Epinephrine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Gabriel Schouten - Clinical Research Coordinator
• Organization: Mayo Clinic

schouten.gabriel@mayo.edu

507-266-5895

Study Officials

• Matthew P Abdel, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 12, 2022
• Study Start: March 11, 2022
• Primary Completion: April 18, 2024
• Study Completion: April 18, 2024
• Last Updated: April 27, 2025
• Results First Posted: April 27, 2025

Record last verified: 2025-04

Locations

US (1)