MedPath

Meloxicam for Pain Management After Total Joint Arthroplasty (TJA)

Phase 3
Completed
Conditions
Total Hip Replacement
Total Knee Replacement
Interventions
Registration Number
NCT05291598
Lead Sponsor
University of Miami
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
223
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. 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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
IV meloxicam groupIV meloxicamParticipants will receive the institution specific joint replacement pain protocol, however with IV meloxicam substituted for ketorolac.
Ketorolac groupKetorolacParticipants will receive the institution specific joint replacement pain protocol, including ketorolac.
Primary Outcome Measures
NameTimeMethod
Pain Measured by the Numeric Rating Scale24 hours postoperatively

A numeric pain rating scale will be used - a higher pain score would indicate higher pain levels. It is scaled 0-10.

Secondary Outcome Measures
NameTimeMethod
Length of Stay as Measured by Same Day DischargesFrom surgery until discharge

The number of patients which were able to be discharged home the same day as their surgical procedure

Opioid Consumption as Measured by Morphine Milligram Equivalents (MME)Within 24 hours postoperatively

The amount of opioids a patient consumes converted into MME for standard comparisons

Renal Injury as Measured by the Change in Creatinine LevelsFrom preoperative baseline labs while hospitalized, up to 1 week

The change in creatinine levels per patient as by comparing their standard preoperative lab creatinine values with the standard postoperative lab creatinine values before discharge from the hospital after their procedure, up to 1 week postoperatively.

Nausea Score as Measured by a Likert Scale24 hours postoperatively

Patients select a score to indicate the severity of their nausea. Scores of 0, 1-2, 3-6, and 7-9 indicate no nausea, mild nausea, moderate nausea, and severe nausea, respectively. The score 10 is assigned to vomiting.

Length of Stay as Measured by Hospital NightsFrom surgery until discharge

The total number of overnights spent in the hospital between surgery and discharge

Length of Stay as Measured by Hours in the HospitalUntil patient discharged from the hospital

Length of stay for the patient as measured in hours from surgery until the moment of discharge

Trial Locations

Locations (1)

University of Miami

🇺🇸

Miami, Florida, United States

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