Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Mallinckrodt | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous acetaminophen | Experimental | Patient receives 1g intravenous acetaminophen after the incision |
|
| Placebo | Placebo Comparator | Patient receives saline injection instead of the study drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen (Ofirmev) | Drug | The patient was administered IV Ofirmev during anesthesia and then 3 more IV doses (1g each) every 6 hours up to 24 hrs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | approximately 30-240 min |
| Hospital Length of Stay | This outcome measure calculates the number of days the patient stayed in the hospital before being discharged home. | 1-3 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0-24 hours after surgery |
| Opioid Use |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Richard Urman, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients were recruited in the preoperative assessment clinic prior to undergoing surgery
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous Acetaminophen | Patient receives 1g intravenous acetaminophen after the incision Acetaminophen (Ofirmev) |
| FG001 | Placebo | Patient receives saline injection instead of the study drug Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
analysis population is the same as the assignment in Participant flow
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous Acetaminophen | Patient receives 1g intravenous acetaminophen after the incision Acetaminophen (Ofirmev) |
| BG001 | Placebo | Patient receives saline injection instead of the study drug Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Patients who had surgery and were then transferred to the post-anesthesia care unit for recovery. | Posted | Mean | Standard Deviation | minutes | approximately 30-240 min |
|
Patients were followed for 30 days after surgery for which adverse events were collected.
Same definition of adverse event was used.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intravenous Acetaminophen | Patient receives 1g intravenous acetaminophen after the incision Acetaminophen (Ofirmev) |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Webber | Brigham and Women's Hospital | (617) 732-6877 | jwebber1@partners.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 16, 2015 | Sep 10, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Other | The patient was administered IV Placebo during anesthesia and then 3 more doses of IV Placebo every 6 hours up to 24 hrs. |
|
A measure of the amount of opioid study patients used postoperatively while recovering from surgery at the hospital
| 0-24 hours |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Hospital Length of Stay | This outcome measure calculates the number of days the patient stayed in the hospital before being discharged home. | Patients who were admitted to the hospital (as inpatients) following surgery and post-anesthesia care unit stay. | Posted | Median | 95% Confidence Interval | Days | 1-3 days |
|
|
|
| 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. | Patients who were assessed for levels of pain following surgery, including both treatment and placebo arms. | Posted | Mean | Inter-Quartile Range | score on a scale | 0-24 hours after surgery |
|
|
|
| Secondary | Opioid Use | A measure of the amount of opioid study patients used postoperatively while recovering from surgery at the hospital | Patients who underwent surgery and stayed in the hospital as inpatients and received pain management. | Posted | Median | Inter-Quartile Range | morphine milligram equivalents | 0-24 hours |
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | Placebo | Patient receives saline injection instead of the study drug Placebo | 0 | 41 | 0 | 41 | 0 | 41 |
Not provided
Not provided
| Aniline Compounds |
| D000588 | Amines |