Hispanics, Multimodal Analgesia, Opioid Use, Pain, Total Knee Arthroplasty
Conditions
Keywords
Total Knee Arthroplasty, Postoperative Pain, Opioid Use, Hispanics, Clinical Outcomes, Multimodal Analgesia
Brief summary
An alternate perioperative pain control protocol composed of intravenous ketorolac and oral acetaminophen for patients who underwent total knee replacement was designed with the aim to determine its efficacy when compared to pain control with intravenous morphine and oral oxycodone combined with acetaminophen. In addition, the study will evaluate the differences and similarities in the Hispanic population that could predict protocol efficacy.
Detailed description
Acute pain after a surgical procedure may occur secondary to trauma from the procedure itself or from procedure-related complications. Appropriate peri-operative acute pain management is an important phase of patient's recovery since it's under-treatment can lead to adverse outcomes such as: thromboembolic and pulmonary complications, additional time spent in an intensive care unit or hospital, hospital readmission for further pain management, needless suffering, impairment of health-related quality of life, and development of chronic pain. Furthermore, it's over-treatment with opioid medications is associated with an increased risk of thromboembolic, infectious and gastrointestinal complications as well as increased length of hospital stay, cost of care and risk of opioid addiction. Perioperative administration of intravenous (IV) non steroidal anti-inflammatory drugs (NSAID), such as ketorolac, has been shown to effectively decrease opioid requirements and pain levels while demonstrating tolerable side effects. Its use after total knee replacement has been associated with a 27% decrease in the use of morphine. When NSAID is combined with acetaminophen 1000mg every six hours, an additional benefit in terms of improved pain scores on post-operative day three was shown in patients who underwent total hip or knee arthroplasty. Therefore, the purpose of this study is to provide an effective alternative for pain management in Hispanic patients who underwent total knee replacement and evaluate the role of ketorolac and acetaminophen.
Interventions
DRUGOpioid based protocol
Use of combination of drug dosage frequency and duration of morphine injection with percocet oral as standard postoperative pain control for up to 72 hours as requested by each patient
DRUGOpioid sparing protocol
Use of combination of drug dosage frequency and duration of ketorolac injection with acetaminophen oral as standard postoperative pain control for up to 72 hours as requested by each patient
Sponsors
University of Puerto Rico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
Inclusion criteria
* Hispanic American patients undergoing primary total knee arthroplasty * Older than 21 years of age * Classified with an American Society of Anesthesiologist Classification (ASA) of I or II.
Exclusion criteria
* Hypersensitivity to any components of analgesic drugs * Impaired renal, cardiac, or hepatic function * Baseline serum creatinine level higher than 1.2mg/dL * History of gastrointestinal bleeding * Neuromuscular deformities * Inability to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores using numerical rating scale (NRS, 0 to 10) | Post-operative 12 hours after surgery | The amount of pain intensity reported will be measure throughout the numerical rating scale. Each patient will rate their pain intensity on a scale from 0 to 10, where zero represents no pain, whereas 10 represents the most intense pain (e.g., the most intense pain imaginable, the maximum pain intensity as it could be); during the 12 hours postoperative period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Length of Stay | up to 30 days | The number of days per patient from the time of admission to discharge up to 30 days |
| Drug-related adverse events | From the time of surgery after being discharge (0 to 72 hours after surgery) | nausea, dizziness, vomit, tachycardia, pruritus and headache |
Countries
Puerto Rico
Outcome results
None listed