- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01798316
IV Acetaminophen for Postoperative Analgesia
IV Acetaminophen for Postoperative Analgesia After Laparoscopic Cholecystectomy
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
New York
-
Manhasset, New York, Forenede Stater, 11030
- North Shore University Hospital
-
New Hyde Park, New York, Forenede Stater, 11040
- Long Island Jewish Medical Center
-
Syosset, New York, Forenede Stater, 11791
- Syosset Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Subject is undergoing pre-scheduled laparoscopic cholecystectomy;
- American Society of Anesthesiology patient classification status I-II
Exclusion Criteria:
- Regular preoperative use of or opioids,
- Subjects admitted after surgery for postoperative complications other than postoperative pain or PONV.
- Subjects converted to open laparoscopic cholecystectomy
- Known allergy/hypersensitivity to acetaminophen
- Use of opioids prior to commencement of the study (<7 days)
- Patients with chronic pain conditions or disease requiring pain control
- Abnormal liver function
- Known or suspected alcohol, drug or opiate abuse or dependence
- Patients with a BMI of greater than 35
- Other physical, mental or medical conditions that could effect participation.
- Abnormal renal function; serum creatinine>2gm/dl
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: IV Acetaminophen
IV Acetaminophen administered on admission to post-anesthesia care unit
|
Single dose, 1000g mg infusion over 15 minutes plus standard of care pain management regimen
Andre navne:
|
Aktiv komparator: Standard of care
Standard of care pain management regimen including opioids administered on admission to post-anesthesia care unit
|
Standard of care pain management regimen, no IV Acetaminophen,
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With Postoperative Nausea and Vomiting (PONV).
Tidsramme: 4 hours plus/minus 30 minutes
|
Number of participants with postoperative nausea and vomiting (PONV) will be recorded during PACU stay. PONV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching. |
4 hours plus/minus 30 minutes
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With Post Discharge Nausea and Vomiting (PDNV)
Tidsramme: Up to two days following surgery
|
Number of participants reporting post discharge nausea and vomiting (PDNV) documented up to 2 days following surgery. PDNV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching following discharge. |
Up to two days following surgery
|
Highest Pain Intensity Score Using Numeric Rating Scale (NRS)
Tidsramme: 4 hours plus/minus 30 minutes
|
Highest pain intensity reported during PACU stay using a 11-point (0-10) pain intensity numeric rating scale (NRS).
Higher values represent higher pain intensities.
|
4 hours plus/minus 30 minutes
|
Patient Satisfaction on a 5 Point Likert Scale
Tidsramme: Up to one week following surgery
|
Number of patients very satisfied or satisfied with pain and PONV management during hospital stay
|
Up to one week following surgery
|
Pain Intensity Score 1 Hour Following Surgery Using Numeric Rating Scale
Tidsramme: 1 hour following surgery
|
Pain intensity score reported by participants 1 hour following surgery using an 11-point, 0-10 Numeric Rating Scale (NRS).
Higher scores indicate higher pain intensities
|
1 hour following surgery
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Patients Requiring Rescue Analgesia for Breakthrough Pain
Tidsramme: 1 hour following surgery
|
Number of patients requiring rescue analgesia medication during first hour of PACU stay
|
1 hour following surgery
|
Narcotic Use During PACU Stay
Tidsramme: 4 hours plus/minus 30 minutes
|
Narcotic medication administered during PACU stay in morphine milligram equivalents
|
4 hours plus/minus 30 minutes
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Frank J Overdyk, MD, Northwell Health
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Postoperative komplikationer
- Tegn og symptomer, fordøjelsessystemet
- Kvalme
- Opkastning
- Postoperativ kvalme og opkastning
- Lægemidlers fysiologiske virkninger
- Agenter fra det perifere nervesystem
- Analgetika
- Sensoriske systemagenter
- Analgetika, ikke-narkotisk
- Antipyretika
- Acetaminophen
Andre undersøgelses-id-numre
- 12-0409
- IRB #12-409B (Anden identifikator: North Shore-Long Island Jewish Health System)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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