A Phase 4 interventional study of Acetaminophen (Ofirmev) and Placebo in Prostatectomy and Pain, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to male participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-11.
Sponsored by Brigham and Women's Hospital · Phase 4, Interventional, and Treatment
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.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's enrollment of 86 is above the median of 70 across 2,101 interventional studies indexed under Pain.
Browse Pain studies →Brigham and Women's Hospital is the lead sponsor of 1,263 studies on the registry; 225 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
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Exclusion Criteria:
Patient receives 1g intravenous acetaminophen after the incision
Drug: Acetaminophen (Ofirmev)
Patient receives saline injection instead of the study drug
Other: Placebo
The patient was administered IV Ofirmev during anesthesia and then 3 more IV doses (1g each) every 6 hours up to 24 hrs.
Also known as: Ofirmev
The patient was administered IV Placebo during anesthesia and then 3 more doses of IV Placebo every 6 hours up to 24 hrs.
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
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
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
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
Patients were recruited in the preoperative assessment clinic prior to undergoing surgery
| Milestone | Intravenous Acetaminophen | Placebo |
|---|---|---|
| Started | 43 | 43 |
| Completed | 43 | 41 |
| Not completed | 0 | 2 |
The amount of time patients stayed in the post-anesthesia care unit following anesthesia, before going to the inpatient ward.
| minutes | Intravenous Acetaminophen | Placebo |
|---|---|---|
| Post Anesthesia Care Unit Length of Stay | 124 ± 58.26 | 132 ± 62.58 |
This outcome measure calculates the number of days the patient stayed in the hospital before being discharged home.
| Days | Intravenous Acetaminophen | Placebo |
|---|---|---|
| Hospital Length of Stay | 0.81 (0.71 to 0.90) | 0.82 (0.66 to 0.95) |
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.
| score on a scale | Intravenous Acetaminophen | Placebo |
|---|---|---|
| Pain Score | 0.62 (0.13 to 1.00) | 0.88 (0.38 to 2.00) |
A measure of the amount of opioid study patients used postoperatively while recovering from surgery at the hospital
| morphine milligram equivalents | Intravenous Acetaminophen | Placebo |
|---|---|---|
| Opioid Use | 42 (36.4 to 50.0) | 50 (35.6 to 72.0) |
Collected over Patients were followed for 30 days after surgery for which adverse events were collected.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intravenous Acetaminophen | 0/43 (0%) | 0/43 (0%) | 0/43 (0%) |
| Placebo | 0/41 (0%) | 0/41 (0%) | 0/41 (0%) |
analysis population is the same as the assignment in Participant flow
| Age, Categorical(Participants) | Intravenous Acetaminophen | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 14 | 16 | 30 |
| >=65 years | 29 | 25 | 54 |
| Age, Continuous(years) | Intravenous Acetaminophen | Placebo | Total |
|---|---|---|---|
| Mean | 63.6 ± 6.1 | 60.2 ± 6.3 | 61.7 ± 6.0 |
| Sex: Female, Male(Participants) | Intravenous Acetaminophen | Placebo | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 43 | 41 | 84 |
| Race and Ethnicity Not Collected(Participants) | Intravenous Acetaminophen | Placebo | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Intravenous Acetaminophen | Placebo | Total |
|---|---|---|---|
| United States | 43 | 41 | 84 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Sep 2015 to primary completion in Jan 2018, 28 months.
Results were first posted in Sep 2019, 1 year 8 months after primary completion.
Of 54 non-industry phase 4 interventional studies under Pain, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's 28 months is above that.
Counting every sponsor, half of 60 studies reached it within 20 months; a quarter within 9 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Acetaminophen
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