Efficacy of NSAID and Acetaminophen in the Control of Post-Operative Pain in Patients Undergoing Total Knee Replacement

University of Puerto Rico (UPR)

Status: Completed

Conditions: Hispanics; Multimodal Analgesia; Opioid Use; Pain; Total Knee Arthroplasty

Treatments: Drug: Opioid sparing protocol; Drug: Opioid based protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT05393414

B0110219

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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81 participants in 2 patient groups

Opioid Sparing Multimodal Regimen

Experimental group

Description:

After surgery, the experimental group will receive a combination of ketorolac 30 mg intravenous (IV) every six hours for patients younger than 65 years old or ketorolac 15mg IV every six hours for those older than 65 years old; and acetaminophen 1 gram by mouth (PO) every six hours up to 72 hours

Treatment:

Drug: Opioid sparing protocol

Opioid Based Multimodal Regimen

Experimental group

Description:

After surgery, the control group will receive a combination of morphine 0.1 mg/kg IV every six hours and oxycodone combined with acetaminophen (2.5 mg / 325 mg) two tabs PO every six hours up to 72 hours

Treatment:

Drug: Opioid based protocol