Meloxicam for Pain Management After Total Joint Arthroplasty (TJA)
Study Details
Study Description
Brief 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).
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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.
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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.
|
Outcome Measures
Primary Outcome Measures
- Change in pain score [2 hours, 24 hours]
A numeric pain rating scale will be used- a higher pain score would indicate higher pain levels. It is scaled from 0-10.
Secondary Outcome Measures
- Change in Opioid Consumption [24 hours]
Total opioid consumption in the immediate post-operative period (IV vs oral) will be measured by converting narcotics to morphine milliequivalents.
- Change in patient nausea scores and vomiting scores [2 hours, 24 hours]
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.
- Duration of hospital stay [24 hours]
This will be measured as the 24 hour period immediately post operatively and will be measured from the time of surgical completion.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients over the age of 18,
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Patients undergoing primary total knee or primary total hip replacement at the University of Miami Hospital,
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Patients that have capacity to provide medical consent
Exclusion Criteria:
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All patients under the age of 18
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Prisoners, diabetics, increased risk of bleeding, and pregnant women.
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Patients with prior surgery or history of infection on the joint of interest.
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Patients with an estimated glomerular filtration rate (eGFR) <50 ml/min
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Patients on dialysis or renal transplant.
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Patients on steroid preoperatively.
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Allergy to sulfas
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Celebrex inability to provide medical consent.
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Miami | Miami | Florida | United States | 33136 |
Sponsors and Collaborators
- University of Miami
Investigators
- Principal Investigator: Victor H Hernandez, MD, University of Miami
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20211214