Pharmacoeconomics and Related Patient Outcomes of Multi-dose Intravenous Acetaminophen (OFIRMEV)
Pharmacoeconomics and Related Patient Outcomes of Multi-dose Intravenous Acetaminophen (OFIRMEV) in Patients Undergoing Robotic-assisted Laparoscopic Prostatectomy
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Although IV acetaminophen has been studied in urologic surgery, it has not been studied specifically in prostatectomies, and therefore there are no outcomes or cost-effectiveness data currently available. In addition, the current trend is to perform prostatectomy with a robot-assisted laparoscopic technique to help minimize incision size, blood loss, postoperative pain, and speed up patient recovery. Current literature only includes the use of opioids in the perioperative setting for robot-assisted prostatectomy to treat pain, but only a small trial used oral acetaminophen as a measure for analgesia in RALP. In addition to the decreasing use of opioids in perioperative pain management, emphasis has been placed on reducing costs of healthcare. A major contributor to this issue is hospital length of stay (LOS) and there has been increased pressure on healthcare providers to decrease overall LOS. Several factors may contribute to hospital LOS, including hospital acquired infections, surgical recovery, wound care, other surgical and anesthesia-related complications, and importantly, inadequate pain control.
In this study we examine the impact of adding IV acetaminophen to the multimodal analgesic regimen for robotic-assisted laparoscopic prostatectomy (RALP). Our hypothesis is that the addition of IV acetaminophen can improve postoperative recovery time, inpatient LOS, postoperative pain scores, and opioid consumption.
This study specifically addresses pharmacoeconomics of IV acetaminophen. The goal is to understand its potential to improve hospital efficiency and patient outcomes. The study compares the impact of the addition of IV acetaminophen versus a placebo on postoperative anesthesia care unit recovery times, inpatient LOS, postoperative pain scores, consumption of opiates as rescue agents and side effects in patients undergoing RALP.
The study is a 2-arm, double-blind, randomized, placebo controlled trial comparing IV acetaminophen to a control (IV placebo). All patients in this study were scheduled to undergo RALP.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02115
- Brigham and Women's Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients undergoing robotic-assisted laparoscopic prostatectomy
- ≥18 years old males
- American Society of Anesthesiologists class 1-4
Exclusion Criteria:
- Chronic opiate use
- Liver disease (known history of hepatitis B or C, cirrhosis, nonalcoholic steatohepatitis, history of alcoholism, liver function test results greater than 3 times upper limit of normal in the past 3 months)
- Allergy/hypersensitivity to acetaminophen
- Patients with baseline dementia
- Chronic diathesis
- Chronic kidney disease
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intravenous acetaminophen
Patient receives 1g intravenous acetaminophen after the incision
|
The patient was administered IV Ofirmev during anesthesia and then 3 more IV doses (1g each) every 6 hours up to 24 hrs.
Andre navne:
|
|
Placebo komparator: Placebo
Patient receives saline injection instead of the study drug
|
The patient was administered IV Placebo during anesthesia and then 3 more doses of IV Placebo every 6 hours up to 24 hrs.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Post Anesthesia Care Unit Length of Stay
Tidsramme: approximately 30-240 min
|
The amount of time patients stayed in the post-anesthesia care unit following anesthesia, before going to the inpatient ward.
|
approximately 30-240 min
|
|
Hospital Length of Stay
Tidsramme: 1-3 days
|
This outcome measure calculates the number of days the patient stayed in the hospital before being discharged home.
|
1-3 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain Score
Tidsramme: 0-24 hours after surgery
|
Pain scores were collected using the Visual Analog Scale. The scale range is 0 (no pain) to 10 (most pain). Mean pain score over first 24 hours postoperatively was collected. |
0-24 hours after surgery
|
|
Opioid Use
Tidsramme: 0-24 hours
|
A measure of the amount of opioid study patients used postoperatively while recovering from surgery at the hospital
|
0-24 hours
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Richard Urman, MD, Brigham and Women's Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
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
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2014P002749
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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