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: Institution specific joint replacement pain protocol; Drug: Ketorolac; Drug: IV meloxicam

• Study Type: Interventional
• Enrollment (Actual): 231
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Joshua E Ovadia, BSc; Phone Number: 3058493207; Email: jeo55@med.miami.edu

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. Celebrex 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.	Drug: Institution specific joint replacement pain protocol; Participants will be treated with a standard orthopaedic joint replacement protocol which includes: Dexamethasone; Tylenol; Lyrica; Celebrex; Meloxicam; Oxycodone; 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 be given IV meloxicam for pain management post total knee and hip arthroplasty.	Drug: Institution specific joint replacement pain protocol; Participants will be treated with a standard orthopaedic joint replacement protocol which includes: Dexamethasone; Tylenol; Lyrica; Celebrex; Meloxicam; Oxycodone; 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
Change in pain score	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, 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Opioid Consumption	Total opioid consumption in the immediate post-operative period (IV vs oral) will be measured by converting narcotics to morphine milliequivalents.	24 hours
Change in patient nausea scores and vomiting scores	The Apfel score will be used to measure this change. This is a simplified scoring system which is based on four independent risk predictors (0-4) which include: female gender, smoking status, history of postoperative nausea and vomiting, and postoperative opioid consumption. 0 is the lowest score and represents the lowest risk with 4 representing the highest risk. This score will be compared to the nausea and vomiting incidence found in patients for each level to this model.	2 hours, 24 hours
Duration of hospital stay	This will be measured as the 24 hour period immediately post operatively and will be measured from the time of surgical completion.	24 hours

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): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

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