Meloxicam for Pain Management After Total Joint Arthroplasty (TJA)

NCT05291598 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 20211214
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 1

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).

Conditions

Total Knee Replacement; Total Hip Replacement

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Nausea Score as Measured by a Likert Scale

  2 hours postoperatively

• Nausea Score as Measured by a Likert Scale

  24 hours postoperatively

• Length of Stay as Measured by Hours in the Hospital

  Until patient discharged from the hospital

• Length of Stay as Measured by Hospital Nights

  From surgery until discharge

• Length of Stay as Measured by Same Day Discharges

  From surgery until discharge

Study Arms (2)

Ketorolac group

ACTIVE COMPARATOR

Participants will receive the institution specific joint replacement pain protocol, including ketorolac.

Drug: Ketorolac

IV meloxicam group

EXPERIMENTAL

Participants will receive the institution specific joint replacement pain protocol, however with IV meloxicam substituted for ketorolac.

Drug: IV meloxicam

Interventions

IV meloxicam DRUG

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

IV meloxicam group

Ketorolac DRUG

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.

Ketorolac group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (1)

• Rizzo MG, Costello JP 2nd, Constantinescu DS, Samineni AV, Moore MR, Shittu AT, Tabibi O, Osman BM, Fiala RS, D'Apuzzo MR, Hernandez VH. Intravenous Meloxicam Versus Ketorolac for Pain Control Following Total Joint Arthroplasty: A Double-Blind Randomized Controlled Trial. J Arthroplasty. 2025 Oct 28:S0883-5403(25)01331-2. doi: 10.1016/j.arth.2025.10.052. Online ahead of print.

  PMID: 41167538 DERIVED

MeSH Terms

Interventions

Meloxicam; Ketorolac

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Victor Hernandez
• Organization: University of Miami Department of Orthopedics

vhh1@miami.edu

(305) 689-5195

Study Officials

• Victor H Hernandez, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Chief - Division of Arthroplasty & Adult Reconstruction, Department of Orthopaedics

Study Record Dates

• First Submitted: March 12, 2022
• First Posted: March 22, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: August 14, 2024
• Results First Posted: August 14, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)