Clinical trial NCT05393414: Efficacy of NSAID and Acetaminophen in the Control of Post-Operative Pain in Patients Undergoing Total Knee Replacement
Official title: Efficacy of NSAID and Acetaminophen in the Control of Post-Operative Pain in Patients Undergoing Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Hispanics
Opioid Use
Multimodal Analgesia
Total Knee Arthroplasty
Keywords: Total Knee Arthroplasty
Postoperative Pain
Opioid Use
Hispanics
Clinical Outcomes
Multimodal Analgesia
Lead sponsor: University of Puerto Rico
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain scores using numerical rating scale (NRS, 0 to 10)
timeFrame: Post-operative 12 hours after surgery
measure: Pain scores using numerical rating scale (NRS, 0 to 10)
timeFrame: Post-operative 24 hours after surgery
measure: Pain scores using numerical rating scale (NRS, 0 to 10)
timeFrame: Post-operative 48 hours after surgery
Secondary outcomes:
measure: Hospital Length of Stay
timeFrame: up to 30 days
measure: Drug-related adverse events
timeFrame: From the time of surgery after being discharge (0 to 72 hours after surgery)
Other outcomes:
Locations:
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico Medical Sciences Campus, Ortopaedic Surgery Department
Study officials:
affiliation: Orthopaedic Surgery Section, University of Puerto Rico Medical Sciences Campus San Juan, Puerto Rico
name: Antonio Otero-Lopez, MD
role: PRINCIPAL_INVESTIGATOR
References: