Efficacy of NSAID and Acetaminophen in the Control of Post-Operative Pain in Patients Undergoing Total Knee Replacement
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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San Juan, Puerto Rico, 00936
- University of Puerto Rico Medical Sciences Campus, Ortopaedic Surgery Department
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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
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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
Andere Namen:
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Experimental: 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
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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
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Pain scores using numerical rating scale (NRS, 0 to 10)
Zeitfenster: Post-operative 12 hours after surgery
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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
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Post-operative 12 hours after surgery
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Pain scores using numerical rating scale (NRS, 0 to 10)
Zeitfenster: Post-operative 24 hours after surgery
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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
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Post-operative 24 hours after surgery
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Pain scores using numerical rating scale (NRS, 0 to 10)
Zeitfenster: Post-operative 48 hours after surgery
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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
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Post-operative 48 hours after surgery
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Hospital Length of Stay
Zeitfenster: up to 30 days
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The number of days per patient from the time of admission to discharge up to 30 days
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up to 30 days
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Drug-related adverse events
Zeitfenster: From the time of surgery after being discharge (0 to 72 hours after surgery)
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nausea, dizziness, vomit, tachycardia, pruritus and headache
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From the time of surgery after being discharge (0 to 72 hours after surgery)
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Antonio Otero-Lopez, MD, Orthopaedic Surgery Section, University of Puerto Rico Medical Sciences Campus San Juan, Puerto Rico
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Pathologische Prozesse
- Postoperative Komplikationen
- Schmerzen
- Neurologische Manifestationen
- Schmerzen, postoperativ
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Depressiva des zentralen Nervensystems
- Agenten des peripheren Nervensystems
- Enzym-Inhibitoren
- Analgetika
- Agenten des sensorischen Systems
- Entzündungshemmende Mittel, nichtsteroidal
- Analgetika, nicht narkotisch
- Entzündungshemmende Mittel
- Antirheumatika
- Cyclooxygenase-Inhibitoren
- Antipyretika
- Betäubungsmittel
- Ketorolac
- Paracetamol
- Morphium
- Analgetika, Opioide
Andere Studien-ID-Nummern
- B0110219
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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