Efficacy of NSAID and Acetaminophen in the Control of Post-Operative Pain in Patients Undergoing Total Knee Replacement
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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San Juan, Porto Rico, 00936
- University of Puerto Rico Medical Sciences Campus, Ortopaedic Surgery Department
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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
Altri nomi:
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Sperimentale: 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
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Pain scores using numerical rating scale (NRS, 0 to 10)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Hospital Length of Stay
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Antonio Otero-Lopez, MD, Orthopaedic Surgery Section, University of Puerto Rico Medical Sciences Campus San Juan, Puerto Rico
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Complicanze postoperatorie
- Dolore
- Manifestazioni neurologiche
- Dolore, Postoperatorio
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Depressori del sistema nervoso centrale
- Agenti del sistema nervoso periferico
- Inibitori enzimatici
- Analgesici
- Agenti del sistema sensoriale
- Agenti antinfiammatori, non steroidei
- Analgesici, non narcotici
- Agenti antinfiammatori
- Agenti antireumatici
- Inibitori della ciclossigenasi
- Antipiretici
- Narcotici
- Ketorolac
- Acetaminofene
- Morfina
- Analgesici, oppioidi
Altri numeri di identificazione dello studio
- B0110219
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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