Pain, Prostatectomy
Conditions
Keywords
acetaminophen
Brief summary
To examine pharmacoeconomics of IV acetaminophen (Ofirmev). Specifically, to examine its potential to improve hospital efficiency and patient outcomes. The investigators compare the addition of IV acetaminophen versus placebo on postoperative anesthesia care unit recovery times, inpatient hospital length of stay (LOS), postoperative pain scores, consumption of opiates as rescue agents and side effects among patients undergoing robotic-assisted laparoscopic prostatectomy (RALP).
Detailed description
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.
Interventions
DRUGAcetaminophen (Ofirmev)
The patient was administered IV Ofirmev during anesthesia and then 3 more IV doses (1g each) every 6 hours up to 24 hrs.
OTHERPlacebo
The patient was administered IV Placebo during anesthesia and then 3 more doses of IV Placebo every 6 hours up to 24 hrs.
Sponsors
Mallinckrodt
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Anesthesia Care Unit Length of Stay | approximately 30-240 min | The amount of time patients stayed in the post-anesthesia care unit following anesthesia, before going to the inpatient ward. |
| Hospital Length of Stay | 1-3 days | This outcome measure calculates the number of days the patient stayed in the hospital before being discharged home. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | 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. |
| Opioid Use | 0-24 hours | A measure of the amount of opioid study patients used postoperatively while recovering from surgery at the hospital |
Countries
United States
Participant flow
Recruitment details
Patients were recruited in the preoperative assessment clinic prior to undergoing surgery
Participants by arm
| Arm | Count |
|---|---|
| Intravenous Acetaminophen Patient receives 1g intravenous acetaminophen after the incision
Acetaminophen (Ofirmev) | 43 |
| Placebo Patient receives saline injection instead of the study drug
Placebo | 41 |
| Total | 84 |
Baseline characteristics
| Characteristic | Placebo | Total | Intravenous Acetaminophen |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 25 Participants | 54 Participants | 29 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 30 Participants | 14 Participants |
| Age, Continuous | 60.2 years STANDARD_DEVIATION 6.3 | 61.7 years STANDARD_DEVIATION 6 | 63.6 years STANDARD_DEVIATION 6.1 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 41 participants | 84 participants | 43 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 41 Participants | 84 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 41 |
| other Total, other adverse events | 0 / 43 | 0 / 41 |
| serious Total, serious adverse events | 0 / 43 | 0 / 41 |
Outcome results
Primary
Hospital Length of Stay
This outcome measure calculates the number of days the patient stayed in the hospital before being discharged home.
Time frame: 1-3 days
Population: Patients who were admitted to the hospital (as inpatients) following surgery and post-anesthesia care unit stay.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Acetaminophen | Hospital Length of Stay | 0.81 Days |
| Placebo | Hospital Length of Stay | 0.82 Days |
Primary
Post Anesthesia Care Unit Length of Stay
The amount of time patients stayed in the post-anesthesia care unit following anesthesia, before going to the inpatient ward.
Time frame: approximately 30-240 min
Population: Patients who had surgery and were then transferred to the post-anesthesia care unit for recovery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Acetaminophen | Post Anesthesia Care Unit Length of Stay | 124 minutes | Standard Deviation 58.26 |
| Placebo | Post Anesthesia Care Unit Length of Stay | 132 minutes | Standard Deviation 62.58 |
Secondary
Opioid Use
A measure of the amount of opioid study patients used postoperatively while recovering from surgery at the hospital
Time frame: 0-24 hours
Population: Patients who underwent surgery and stayed in the hospital as inpatients and received pain management.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Acetaminophen | Opioid Use | 42 morphine milligram equivalents |
| Placebo | Opioid Use | 50 morphine milligram equivalents |
Secondary
Pain Score
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.
Time frame: 0-24 hours after surgery
Population: Patients who were assessed for levels of pain following surgery, including both treatment and placebo arms.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intravenous Acetaminophen | Pain Score | 0.62 score on a scale |
| Placebo | Pain Score | 0.88 score on a scale |