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Completed

NCT Number: NCT05291598

Meloxicam for Pain Management After Total Joint Arthroplasty (TJA)

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).

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Key information

Conditions

Total Knee Replacement Total Hip Replacement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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.

Treatment and study plan

IV meloxicam

Drug

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

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.

Primary outcomes

  1. Pain Measured by the Numeric Rating Scale

    Time frame: 2 hours postoperatively

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

  2. Pain Measured by the Numeric Rating Scale

    Time frame: 24 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 outcomes

  1. Nausea Score as Measured by a Likert Scale

    Time frame: 2 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.

  2. Nausea Score as Measured by a Likert Scale

    Time frame: 24 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.

  3. Length of Stay as Measured by Hours in the Hospital

    Time frame: Until patient discharged from the hospital

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

  4. Length of Stay as Measured by Hospital Nights

    Time frame: From surgery until discharge

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

  5. Length of Stay as Measured by Same Day Discharges

    Time frame: From surgery until discharge

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

  6. Opioid Consumption as Measured by Morphine Milligram Equivalents (MME)

    Time frame: Within 2 hours postoperatively

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

  7. Opioid Consumption as Measured by Morphine Milligram Equivalents (MME)

    Time frame: Within 24 hours postoperatively

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

  8. Renal Injury as Measured by the Change in Creatinine Levels

    Time frame: From 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

IV Meloxicam for Pain Management Post TJA: Prospective Randomized Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 22, 2022
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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