Meloxicam for Pain Management After Total Joint Arthroplasty (TJA)

Study Overview
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Brief Summary
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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).

Official Title
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IV Meloxicam for Pain Management Post TJA: Prospective Randomized Trial

Conditions
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Total Knee Replacement, Total Hip Replacement

Intervention / Treatment
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* Drug: Institution specific joint replacement pain protocol
* Drug: IV meloxicam
* Drug: Ketorolac


Participation Criteria
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Eligibility Criteria
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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 Celebrex 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketorolac group<br>Participants will receive the institution specific joint replacement pain protocol. | Drug: Institution specific joint replacement pain protocol<br>* Participants will be treated with a standard orthopaedic joint replacement protocol which includes: Dexamethasone Tylenol Lyrica Celebrex Meloxicam Oxycodone<br>Drug: Ketorolac<br>* 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.<br>|
| Experimental: IV meloxicam group<br>Participants will be given IV meloxicam for pain management post total knee and hip arthroplasty. | Drug: Institution specific joint replacement pain protocol<br>* Participants will be treated with a standard orthopaedic joint replacement protocol which includes: Dexamethasone Tylenol Lyrica Celebrex Meloxicam Oxycodone<br>Drug: IV meloxicam<br>* Participants will be administered meloxicam 30 mg IV push pre-operatively.<br>|

What is the study measuring?
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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 |