Meloxicam for Pain Management After Total Joint Arthroplasty (TJA)

IV Meloxicam for Pain Management Post TJA: Prospective Randomized Trial

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).

Study Overview

• Status: Completed
• Conditions: Total Hip Replacement; Total Knee Replacement
• Intervention / Treatment: Drug: Ketorolac; Drug: IV meloxicam

• Study Type: Interventional
• Enrollment (Actual): 223
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. All patients under the age of 18
2. Prisoners, diabetics, increased risk of bleeding, and pregnant women.
3. Patients with prior surgery or history of infection on the joint of interest.
4. Patients with an estimated glomerular filtration rate (eGFR) <50 ml/min
5. Patients on dialysis or renal transplant.
6. Patients on steroid preoperatively.
7. Allergy to sulfas
8. Inability to provide medical consent.
9. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ketorolac group; Participants will receive the institution specific joint replacement pain protocol, including ketorolac.	Drug: Ketorolac; Participants will be treated with ketorolac 15 mg IV push intra-operatively, followed by 15 mg IV push every 6 hours scheduled for 2 doses.
Experimental: IV meloxicam group; Participants will receive the institution specific joint replacement pain protocol, however with IV meloxicam substituted for ketorolac.	Drug: IV meloxicam; Participants will be administered meloxicam 30 mg IV push pre-operatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Measured by the Numeric Rating Scale	A numeric pain rating scale will be used - a higher pain score would indicate higher pain levels. It is scaled from 0-10.	2 hours postoperatively
Pain Measured by the Numeric Rating Scale	A numeric pain rating scale will be used - a higher pain score would indicate higher pain levels. It is scaled 0-10.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nausea Score as Measured by a Likert Scale	Patients select a score to indicate the severity of their nausea. Scores of 0, 1-2, 3-6, and 7-9 indicate no nausea, mild nausea, moderate nausea, and severe nausea, respectively. The score 10 is assigned to vomiting.	2 hours postoperatively
Nausea Score as Measured by a Likert Scale	Patients select a score to indicate the severity of their nausea. Scores of 0, 1-2, 3-6, and 7-9 indicate no nausea, mild nausea, moderate nausea, and severe nausea, respectively. The score 10 is assigned to vomiting.	24 hours postoperatively
Length of Stay as Measured by Hours in the Hospital	Length of stay for the patient as measured in hours from surgery until the moment of discharge	Until patient discharged from the hospital
Length of Stay as Measured by Hospital Nights	The total number of overnights spent in the hospital between surgery and discharge	From surgery until discharge
Length of Stay as Measured by Same Day Discharges	The number of patients which were able to be discharged home the same day as their surgical procedure	From surgery until discharge
Opioid Consumption as Measured by Morphine Milligram Equivalents (MME)	The amount of opioids a patient consumes converted into MME for standard comparisons	Within 2 hours postoperatively
Opioid Consumption as Measured by Morphine Milligram Equivalents (MME)	The amount of opioids a patient consumes converted into MME for standard comparisons	Within 24 hours postoperatively
Renal Injury as Measured by the Change in Creatinine Levels	The change in creatinine levels per patient as by comparing their standard preoperative lab creatinine values with the standard postoperative lab creatinine values before discharge from the hospital after their procedure, up to 1 week postoperatively.	From preoperative baseline labs while hospitalized, up to 1 week

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Victor H Hernandez, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: March 12, 2022
• First Submitted That Met QC Criteria: March 12, 2022
• First Posted (Actual): March 22, 2022

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: July 19, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Ketorolac; Meloxicam
• Other Study ID Numbers: 20211214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No