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Effect of Intravenous Acetaminophen on Postoperative Opioid-related Complications

25 marzo 2021 aggiornato da: Alparslan Turan, The Cleveland Clinic

Some patients have respiratory depression (decreased breaths per minute) after surgery. Acetaminophen, an FDA approved pain medication, may prevent this problem. The purpose of this study is to determine if acetaminophen decreases respiratory depression after surgery. The investigators will also evaluate the cost effectiveness of acetaminophen.

Patients having elective major abdominal surgery are being asked to participate in this research study. If eligible, a patient will have their baseline tidal volume (amount of air moved into or out of the lungs) and vital capacity (how much air the lungs are capable of holding) measured using a spirometer (apparatus for measuring the volume of air inspired and expired by the lungs) measured before surgery. Three questionnaires will also need to be completed before surgery.

The patient will then be randomized, like flipping a coin, to receive either Acetaminophen or placebo (inactive substance) as an infusion throughout surgery and for the first two days thereafter. Neither the patient nor his or her physician will know if the patient is assigned to study drug or placebo. Regardless of study assignment, both groups will receive standard pain management medications and sedation.

After surgery, the patient's blood pressure, activity, posture, respiratory rate, the electrical activity of the heart, oxygen saturation, tidal volume, minute ventilation and respiratory rate will be continuously monitored and recorded for 48 hours using a wireless pulse-oximeter and a respiratory volume monitor.

48 hours after surgery the patient will be asked to complete a patient satisfaction questionnaire, which will allow the patient to rate the satisfaction with the treatment received for pain. The patient will also be asked to complete a questionnaire about recovery.

At discharge, the patient will be given two questionnaires about pain and quality of life.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

580

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Ohio
      • Cleveland, Ohio, Stati Uniti, 44195
        • Cleveland Clinic Foundation

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 85 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Written informed consent
  • 18-85 years old
  • above 50 kg
  • American Society of Anaesthesiologists Physical Status 1-3
  • Scheduled for elective open or laparoscopic abdominal surgery, including colorectal, prostate, and hysterectomy surgeries
  • Patients with anticipated hospitalization of two nights
  • Expected to require parenteral opioids for at least 48 hours for postoperative pain
  • Able to use IV Patient-Controlled Analgesia systems

Exclusion Criteria:

  • Hepatic disease, e.g. twice the normal levels of liver enzymes
  • Kidney disease, e.g. twice the normal level of serum creatinine
  • Epidural analgesia or regional blocks (including Transverse abdominis plane block)
  • Acetaminophen sensitivity or known allergy
  • Female patients who are pregnant or breastfeeding
  • Patients taking warfarin

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Intravenous 0.9% sodium chloride
0.9% sodium chloride infusion will be initiated before the surgical incision with 100 ml and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge.
Droga: Intravenous Acetaminophen
Sperimentale: Intravenous Acetaminophen
Acetaminophen infusion will be initiated before the surgical incision with 1 g and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge.
Droga: Intravenous Acetaminophen

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Duration of Hypoxemia
Lasso di tempo: the initial 48 hours of postoperative monitoring or for the duration of hospitalization, if shorter.
Hypoxemia is measured as minutes with hypoxemia (Spo2 <90%) per hour of successful Spo2 monitoring. Patients will have nearly continuous pulseoximeter monitoring and recording. Data from the monitor will be downloaded daily for 48 hours postoperatively.
the initial 48 hours of postoperative monitoring or for the duration of hospitalization, if shorter.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time-weighted Pain Score During Initial 48 Postoperative Hours
Lasso di tempo: Initial 48 postoperative hours or duration of hospitalization (whichever comes first)
Pain scores were calculated on a visual analog scale of 0 to 10, with 0 being no pain and 10 being the most pain imaginable; time weighted mean was calculated as the area under the curve of the pain score measurements divided by total measurement time. Pain was recorded at roughly 15-minute intervals in the postanesthesia care unit and at 4-hour intervals on surgical wards
Initial 48 postoperative hours or duration of hospitalization (whichever comes first)
Time Weighted Pain Score in Post Anesthesia Care Unit
Lasso di tempo: Initial 48 postoperative hours or duration of hospitalization (whichever comes first)
Pain scores were calculated on a visual analog scale of 0 to 10, with 0 being no pain and 10 being the most pain imaginable; time-weighted mean was calculated as the area under the curve of the pain score measurements divided by total measurement time.
Initial 48 postoperative hours or duration of hospitalization (whichever comes first)
Fatigue Score on Morning of Postoperative Day 1
Lasso di tempo: Postoperative day 1
Fatigue scores were calculated on a scale of 1 to 10, with 1 being no fatigue and 10 being the worst fatigue imaginable.
Postoperative day 1
Lowest RASS Score During Initial 48 Postoperative Hours
Lasso di tempo: Initial 48 postoperative hours or duration of hospitalization (whichever comes first)
Sedation was estimated by the RASS score and recorded at 2-hour intervals by ward nurses per clinical routine during the initial 48 postoperative hours. The Richmond Agitation-Sedation Scale (RASS) is scored from -5 to +4, with -5 being unarousable, 0 being alert and calm, and +4 being combative.
Initial 48 postoperative hours or duration of hospitalization (whichever comes first)
Time Spent in Sitting or Upright Position
Lasso di tempo: Initial 48 postoperative hours or duration of hospitalization (whichever comes first)
Treatment effect data are reported as ratios of geometric means
Initial 48 postoperative hours or duration of hospitalization (whichever comes first)
Opioid Consumption - Intravenous Morphine Equivalents
Lasso di tempo: Initial 48 postoperative hours
Total opioid consumption over the initial 48 postoperative hours was extracted from patients' medical records and converted to intravenous morphine equivalents
Initial 48 postoperative hours
Incidence of Postoperative Nausea and Vomiting
Lasso di tempo: Initial 48 postoperative hours or duration of hospitalization (whichever comes first)
Patients were asked about postoperative nausea and vomiting in the postanesthesia care unit, at 4-hour intervals while awake through the remaining initial day of surgery, and on the first and second postoperative mornings.
Initial 48 postoperative hours or duration of hospitalization (whichever comes first)
Incidence of Low Respiratory Function Event
Lasso di tempo: Initial 48 postoperative hours or duration of hospitalization (whichever comes first)
A low respiratory function event was defined as an episode of less than 40% of predicted minute ventilation for 2 minutes.
Initial 48 postoperative hours or duration of hospitalization (whichever comes first)
Total Anesthetic Dose From Induction to Extubation
Lasso di tempo: Induction to extubation (3 hours on average)
Total anesthetic dose is measured in minimal alveolar concentration hours.
Induction to extubation (3 hours on average)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The Cleveland Clinic

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 dicembre 2014

Completamento primario (Effettivo)

1 marzo 2019

Completamento dello studio (Effettivo)

1 ottobre 2020

Date di iscrizione allo studio

Primo inviato

3 giugno 2014

Primo inviato che soddisfa i criteri di controllo qualità

4 giugno 2014

Primo Inserito (Stima)

5 giugno 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 aprile 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 marzo 2021

Ultimo verificato

1 marzo 2021

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 14-241

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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