Meloxicam for Pain Management After Total Joint Arthroplasty (TJA)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

223 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-05-01

Brief Summary

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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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Detailed Description

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Conditions

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Total Knee Replacement Total Hip Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ketorolac group

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

Group Type ACTIVE_COMPARATOR

Ketorolac

Intervention Type 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.

IV meloxicam group

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

Group Type EXPERIMENTAL

IV meloxicam

Intervention Type DRUG

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

Interventions

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IV meloxicam

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No