Meloxicam for Pain Management After Total Joint Arthroplasty (TJA)

Total Knee Replacement Clinical Trial

Official title:

IV Meloxicam for Pain Management Post TJA: Prospective Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05291598
• Other study ID #: 20211214
• Status: Completed
• Phase: Phase 3
• Start date: May 1, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: May 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Total Hip Replacement
• Total Knee Replacement

Intervention

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
• IV meloxicam
Participants will be administered meloxicam 30 mg IV push pre-operatively.
• 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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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