Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05291598
Other study ID # 20211214
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date May 1, 2022
Est. completion date May 1, 2023

Study information

Verified date May 2023
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 231
Est. completion date May 1, 2023
Est. primary completion date May 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Miami Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in pain score A numeric pain rating scale will be used- a higher pain score would indicate higher pain levels. It is scaled from 0-10. 2 hours, 24 hours
Secondary Change in Opioid Consumption Total opioid consumption in the immediate post-operative period (IV vs oral) will be measured by converting narcotics to morphine milliequivalents. 24 hours
Secondary Change in patient nausea scores and vomiting scores 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. 2 hours, 24 hours
Secondary Duration of hospital stay This will be measured as the 24 hour period immediately post operatively and will be measured from the time of surgical completion. 24 hours
See also
  Status Clinical Trial Phase
Terminated NCT04040985 - Legion Primary Safety and Efficacy N/A
Recruiting NCT05279092 - Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study Phase 2
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Not yet recruiting NCT04594447 - Physica System KR vs Physica System CR (K-20) N/A
Completed NCT02413996 - Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty N/A
Completed NCT01500252 - Patellar Resurfacing Versus Patellar Retention in Total Knee Arthroplasty - A Randomized Clinical Trial Phase 4
Completed NCT04081493 - The Efficacy of Low-load Blood Flow Restricted Resistance Before TKR N/A
Active, not recruiting NCT03339557 - Comparison of Three Knee Replacements N/A
Enrolling by invitation NCT04513145 - Adductor Canal Block Phase 2/Phase 3
Completed NCT06045078 - Aromatherapy in Total Knee Replacement N/A
Completed NCT02468934 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Using the SPRINT System N/A
Completed NCT02914210 - Virtual vs. Traditional Physical Therapy Following Total Knee Replacement N/A
Withdrawn NCT01523418 - Study to Observe Safety of Xarelto in VTE Prophlylaxis After Elective TKR (Total Knee Replacement) or THR (Total Hip Replacement) N/A
Completed NCT00795223 - Comparative Pain Control Between 0.2 or 0.3 Spinal Morphine and 0.25 or 0.5 % Bupivacaine for FNB After TKA Phase 4
Completed NCT01307202 - Morphine Consumption in Joint Replacement Patients, With or Without Gabapentin Treatment N/A
Completed NCT01522781 - 10 Year Outcome of Total Knee Replacement (TKR) Using Sigma Prosthesis N/A
Completed NCT01515449 - Predictors of Poor Outcomes in 1038 Sigma Knees N/A
Completed NCT04166539 - Neurotoxicity and Cardiotoxicity in Total Joint Arthroplasty
Completed NCT03454256 - Virtual Reality Rehabilitation in Patients With Total Knee Replacement N/A
Enrolling by invitation NCT06118073 - Effect of Mindfulness on Pain After Total Knee Arthroplasty N/A