Total Hip Replacement, Total Knee Replacement
Conditions
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).
Interventions
DRUGIV meloxicam
Participants will be administered meloxicam 30 mg IV push pre-operatively.
DRUGKetorolac
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.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Measured by the Numeric Rating Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay as Measured by Hours in the Hospital | Until patient discharged from the hospital | Length of stay for the patient as measured in hours from surgery until the moment of discharge |
| Length of Stay as Measured by Hospital Nights | From surgery until discharge | The total number of overnights spent in the hospital between surgery and discharge |
| Nausea Score as Measured by a Likert Scale | 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. |
| Opioid Consumption as Measured by Morphine Milligram Equivalents (MME) | Within 2 hours postoperatively | The amount of opioids a patient consumes converted into MME for standard comparisons |
| Renal Injury as Measured by the Change in Creatinine Levels | 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. |
| Length of Stay as Measured by Same Day Discharges | From surgery until discharge | The number of patients which were able to be discharged home the same day as their surgical procedure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ketorolac Group Participants will receive the institution specific joint replacement pain protocol.
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
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. | 114 |
| IV Meloxicam Group Participants will be given IV meloxicam for pain management post total knee and hip arthroplasty.
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
IV meloxicam: Participants will be administered meloxicam 30 mg IV push pre-operatively. | 109 |
| Total | 223 |
Baseline characteristics
| Characteristic | Ketorolac Group | IV Meloxicam Group | Total |
|---|---|---|---|
| Age, Continuous | 64.65 years STANDARD_DEVIATION 9.56 | 64.34 years STANDARD_DEVIATION 8.93 | 64.50 years STANDARD_DEVIATION 9.24 |
| Apfel Score for Postoperative Nausea and Vomiting | 1.78 units on a scale STANDARD_DEVIATION 0.9 | 2.00 units on a scale STANDARD_DEVIATION 0.89 | 1.88 units on a scale STANDARD_DEVIATION 0.9 |
| Body Mass Index (BMI) | 30.73 kg/m^2 STANDARD_DEVIATION 5.49 | 31.10 kg/m^2 STANDARD_DEVIATION 5.91 | 30.91 kg/m^2 STANDARD_DEVIATION 5.69 |
| Laterality Bilateral | 1 Participants | 0 Participants | 1 Participants |
| Laterality Left | 56 Participants | 51 Participants | 107 Participants |
| Laterality Right | 57 Participants | 58 Participants | 115 Participants |
| Procedure Total Hip Arthroplasty | 45 Participants | 44 Participants | 89 Participants |
| Procedure Total Knee Arthroplasty | 69 Participants | 65 Participants | 134 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 62 Participants | 60 Participants | 122 Participants |
| Sex: Female, Male Male | 52 Participants | 49 Participants | 101 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 114 | 0 / 109 |
| other Total, other adverse events | 0 / 114 | 0 / 109 |
| serious Total, serious adverse events | 0 / 114 | 0 / 109 |
Outcome results
Primary
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.
Time frame: 2 hours postoperatively
Population: 15 patients in the ketorolac group and 24 in the Meloxicam group did not return survey data in the time period analyzed for this variable and were thus excluded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac Group | Pain Measured by the Numeric Rating Scale | 3.34 units on a scale | Standard Deviation 3.25 |
| IV Meloxicam Group | Pain Measured by the Numeric Rating Scale | 3.32 units on a scale | Standard Deviation 3.39 |
Primary
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.
Time frame: 24 hours postoperatively
Population: 20 patients in the ketorolac group and 25 in the Meloxicam group did not return survey data in the time period analyzed for this variable and were thus excluded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac Group | Pain Measured by the Numeric Rating Scale | 4.06 units on a scale | Standard Deviation 3.07 |
| IV Meloxicam Group | Pain Measured by the Numeric Rating Scale | 3.75 units on a scale | Standard Deviation 3.19 |
Secondary
Length of Stay as Measured by Hospital Nights
The total number of overnights spent in the hospital between surgery and discharge
Time frame: From surgery until discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac Group | Length of Stay as Measured by Hospital Nights | 1.51 nights | Standard Deviation 2.07 |
| IV Meloxicam Group | Length of Stay as Measured by Hospital Nights | 1.63 nights | Standard Deviation 1.4 |
Secondary
Length of Stay as Measured by Hours in the Hospital
Length of stay for the patient as measured in hours from surgery until the moment of discharge
Time frame: Until patient discharged from the hospital
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac Group | Length of Stay as Measured by Hours in the Hospital | 37.87 hours | Standard Deviation 49.81 |
| IV Meloxicam Group | Length of Stay as Measured by Hours in the Hospital | 41.56 hours | Standard Deviation 34.3 |
Secondary
Length of Stay as Measured by Same Day Discharges
The number of patients which were able to be discharged home the same day as their surgical procedure
Time frame: From surgery until discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ketorolac Group | Length of Stay as Measured by Same Day Discharges | 23 Participants |
| IV Meloxicam Group | Length of Stay as Measured by Same Day Discharges | 10 Participants |
Secondary
Nausea Score as Measured by a Likert Scale
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.
Time frame: 2 hours postoperatively
Population: 16 patients in the ketorolac group and 24 in the Meloxicam group did not return survey data in the time period analyzed for this variable and were thus excluded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac Group | Nausea Score as Measured by a Likert Scale | 0.42 score on a scale | Standard Deviation 1.62 |
| IV Meloxicam Group | Nausea Score as Measured by a Likert Scale | 0.54 score on a scale | Standard Deviation 1.8 |
Secondary
Nausea Score as Measured by a Likert Scale
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.
Time frame: 24 hours postoperatively
Population: 21 patients in the ketorolac group and 26 in the Meloxicam group did not return survey data in the time period analyzed for this variable and were thus excluded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac Group | Nausea Score as Measured by a Likert Scale | 0.48 score on a scale | Standard Deviation 1.53 |
| IV Meloxicam Group | Nausea Score as Measured by a Likert Scale | 0.29 score on a scale | Standard Deviation 0.96 |
Secondary
Opioid Consumption as Measured by Morphine Milligram Equivalents (MME)
The amount of opioids a patient consumes converted into MME for standard comparisons
Time frame: Within 2 hours postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac Group | Opioid Consumption as Measured by Morphine Milligram Equivalents (MME) | 1.98 morphine milligram equivalents | Standard Deviation 4.84 |
| IV Meloxicam Group | Opioid Consumption as Measured by Morphine Milligram Equivalents (MME) | 2.00 morphine milligram equivalents | Standard Deviation 3.09 |
Secondary
Opioid Consumption as Measured by Morphine Milligram Equivalents (MME)
The amount of opioids a patient consumes converted into MME for standard comparisons
Time frame: Within 24 hours postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac Group | Opioid Consumption as Measured by Morphine Milligram Equivalents (MME) | 20.59 morphine milligram equivalents | Standard Deviation 26.46 |
| IV Meloxicam Group | Opioid Consumption as Measured by Morphine Milligram Equivalents (MME) | 28.21 morphine milligram equivalents | Standard Deviation 24.22 |
Secondary
Renal Injury as Measured by the Change in Creatinine Levels
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.
Time frame: From preoperative baseline labs while hospitalized, up to 1 week
Population: 28 patients in the ketorolac group and 24 in the Meloxicam group did not have available data in the time period analyzed for this variable and were thus excluded. Both Arm/Groups had the same reporting identical values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac Group | Renal Injury as Measured by the Change in Creatinine Levels | 0.09 mg/dL | Standard Deviation 0.19 |
| IV Meloxicam Group | Renal Injury as Measured by the Change in Creatinine Levels | 0.09 mg/dL | Standard Deviation 0.19 |