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

NCT05188053 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 209

Last updated 2025-04-27

Study results available
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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

Interventions

DRUG

HTX-011

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

DRUG

ropivacaine , epinephrine , ketorolac diluted in sodium chloride

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

Sponsors & Collaborators

Principal Investigators

  • Matthew P Abdel, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-11
Primary Completion
2024-04-18
Completion
2024-04-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05188053 on ClinicalTrials.gov