Phase 3 N=223 Randomized Triple-blind Treatment

Meloxicam for Pain Management After Total Joint Arthroplasty (TJA)

Total Knee Replacement · Total Hip Replacement

Bottom Line

View on ClinicalTrials.gov: NCT05291598 ↗

Enrolled (actual)

223

Serious AEs

0.0%

Results posted

Aug 2024

Primary outcome: Primary: Pain Measured by the Numeric Rating Scale — 3.34; 3.32 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: IV meloxicam (Drug); Ketorolac (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Miami
Primary completion: May 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Measured by the Numeric Rating Scale	4.06; 3.75	—
PRIMARY Pain Measured by the Numeric Rating Scale	4.06; 3.75	—
SECONDARY Nausea Score as Measured by a Likert Scale	0.48; 0.29	—
SECONDARY Nausea Score as Measured by a Likert Scale	0.48; 0.29	—
SECONDARY Length of Stay as Measured by Hours in the Hospital	37.87; 41.56	—
SECONDARY Length of Stay as Measured by Hospital Nights	1.51; 1.63	—
SECONDARY Length of Stay as Measured by Same Day Discharges	23; 10	—
SECONDARY Opioid Consumption as Measured by Morphine Milligram Equivalents (MME)	20.59; 28.21	—
SECONDARY Opioid Consumption as Measured by Morphine Milligram Equivalents (MME)	20.59; 28.21	—
SECONDARY Renal Injury as Measured by the Change in Creatinine Levels	0.09; 0.09	—

Summary

The purpose of this project is to determine if a change in patient reported pain, nausea and vomiting after total knee and hip arthroplasty could be observed with the substitution of Intravenous meloxicam for ketorolac in the current established peri-operative pain protocol and if these changes lead to a decrease in opioid consumption (in morphine equivalents).

Eligibility Criteria

Inclusion Criteria

Patients over the age of 18,
Patients undergoing primary total knee or primary total hip replacement at the University of Miami Hospital,
Patients that have capacity to provide medical consent

Exclusion Criteria

All patients under the age of 18
Prisoners, diabetics, increased risk of bleeding, and pregnant women.
Patients with prior surgery or history of infection on the joint of interest.
Patients with an estimated glomerular filtration rate (eGFR) <50 ml/min
Patients on dialysis or renal transplant.
Patients on steroid preoperatively.
Allergy to sulfas
Inability to provide medical consent.
Any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements will exclude the participant.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05291598). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.