Meloxicam for Pain Management After Total Joint Arthroplasty (TJA)

Sponsor
University of Miami (Other)
Overall Status
Recruiting
CT.gov ID
NCT05291598
Collaborator
(none)
200
1
2
7
28.4

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
  • Drug: Institution specific joint replacement pain protocol
  • Drug: IV meloxicam
  • Drug: Ketorolac
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
IV Meloxicam for Pain Management Post TJA: Prospective Randomized Trial
Actual Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

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

  1. 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

  1. 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.

  2. 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.

  3. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
Victor Hugo Hernandez, Associate Professor, University of Miami
ClinicalTrials.gov Identifier:
NCT05291598
Other Study ID Numbers:
  • 20211214
First Posted:
Mar 22, 2022
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2022