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

23. maj 2022 opdateret af: University of Puerto Rico
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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

81

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Puerto Rico
      • San Juan, Puerto Rico, 00936
        • University of Puerto Rico Medical Sciences Campus, Ortopaedic Surgery Department

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 110 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Opioid Sparing Multimodal Regimen
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
Medicin: Opioid 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
Andre navne:
  • ketorolac injektion
  • acetaminophen oral
Eksperimentel: Opioid Based Multimodal Regimen
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
Medicin: Opioid 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
Andre navne:
  • morfininjektion
  • percocet oral

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain scores using numerical rating scale (NRS, 0 to 10)
Tidsramme: 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
Post-operative 12 hours after surgery
Pain scores using numerical rating scale (NRS, 0 to 10)
Tidsramme: 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
Post-operative 24 hours after surgery
Pain scores using numerical rating scale (NRS, 0 to 10)
Tidsramme: 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
Post-operative 48 hours after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hospital Length of Stay
Tidsramme: up to 30 days
The number of days per patient from the time of admission to discharge up to 30 days
up to 30 days
Drug-related adverse events
Tidsramme: From the time of surgery after being discharge (0 to 72 hours after surgery)
nausea, dizziness, vomit, tachycardia, pruritus and headache
From the time of surgery after being discharge (0 to 72 hours after surgery)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Puerto Rico

Efterforskere

  • Ledende efterforsker: Antonio Otero-Lopez, MD, Orthopaedic Surgery Section, University of Puerto Rico Medical Sciences Campus San Juan, Puerto Rico

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. november 2019

Primær færdiggørelse (Faktiske)

12. marts 2020

Studieafslutning (Faktiske)

12. marts 2020

Datoer for studieregistrering

Først indsendt

13. maj 2022

Først indsendt, der opfyldte QC-kriterier

23. maj 2022

Først opslået (Faktiske)

26. maj 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. maj 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. maj 2022

Sidst verificeret

1. maj 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B0110219

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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