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NCT Number: NCT05393414

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

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.

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Key information

Conditions

Pain Hispanics Multimodal Analgesia Neurologic Manifestations Opioid Use Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Total Knee Arthroplasty

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Puerto Rico Medical Sciences Campus, Ortopaedic Surgery Department

San Juan, 00936, Puerto Rico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Opioid based protocol

Drug

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

Other names: morphine injection, percocet oral

Opioid sparing protocol

Drug

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

Other names: ketorolac injection, acetaminophen oral

Primary outcomes

  1. Pain scores using numerical rating scale (NRS, 0 to 10)

    Time frame: 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

  2. Pain scores using numerical rating scale (NRS, 0 to 10)

    Time frame: Post-operative 24 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 24 hours postoperative period

  3. Pain scores using numerical rating scale (NRS, 0 to 10)

    Time frame: Post-operative 48 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 48 hours postoperative period

Secondary outcomes

  1. Hospital Length of Stay

    Time frame: up to 30 days

    The number of days per patient from the time of admission to discharge up to 30 days

  2. Drug-related adverse events

    Time frame: From the time of surgery after being discharge (0 to 72 hours after surgery)

    nausea, dizziness, vomit, tachycardia, pruritus and headache

Sponsors and collaborators

Lead sponsor

University of Puerto Rico

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 26, 2022
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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