Osteoarthritis, Acetaminophen, Arthroplasty, Hip Replacement
Conditions
Brief summary
The purpose of this study is to determine if intravenous acetaminophen is superior to oral acetaminophen when used as part of a multimodal pathway for primary total hip arthroplasty.
Detailed description
This is a single center, prospective, randomized controlled study. 60 subjects will be recruited (see #6 Recruitment and Compensation below). On the day of surgery, subjects will be randomized to receive either the study intervention (intravenous acetaminophen and placebo tablets) or the control intervention (intravenous saline and active acetaminophen tablets). The Investigational Drug Service will prepare each intervention package, which will include one intravenous and one oral medication dose. Only one of these routes will be active (determined by randomization). Subjects will receive doses of both an intravenous and oral study drug every 6 hours in order to maintain blinding, and will receive a total of 4 doses of each (at 0, 6, 12 and 18 hours). The dose of acetaminophen in all cases will be 1000 mg. The volume of intravenous acetaminophen (and saline) will be 100 mL. The oral dose will consist of two (2) tablets of 500 mg each (or two matching placebo tablets). All subjects will receive a standardized anesthetic regimen for total hip arthroplasty, as follows: A) Preoperative phase Subjects will receive the following preoperative multimodal drugs: * Pregabalin 75 mg PO * Celecoxib 200 mg PO * The interventional drugs, both IV and PO . The time that these drugs are administered will be recorded as time zero. Patients will then receive a spinal anesthetic with 12.5 mg of isobaric bupivacaine. No peripheral nerve blocks will be performed. B) Intraoperative phase All subjects will be receive propofol infusion beginning at 50 mg/kg/min and titrated to a Richmond Agitation-Sedation Scale score of -1 to -3 (drowsy to moderate sedation). Dexamethasone 10 mg IV and ketamine 0.25 mg/kg IV up to 40 mg total will be administered as part of the standard multimodal regimen. If required, subjects may receive fentanyl 25 mcg IV as needed to treat discomfort. No joint infiltration will be performed by the surgeon. C) Postoperative phase In the Post-Anesthesia Care Unit (PACU), subjects will have an intravenous patient-controlled analgesia (IVPCA) device connected and loading doses of hydromorphone administered by the PACU nurse as necessary (0.2 mg q 8 min prn). On the floor, subjects will receive: * Pregabalin 75 mg PO BID until discharge * Celecoxib 200 mg PO BID until discharge * Dexamethasone 10 mg IV x 1 on postoperative day 1 (24 hours after the first dose) * Intravenous patient-controlled analgesia (IVPCA) with hydromorphone (0.2 mg q 8 min). The remaining 3 intervention packages (IV and PO) will be administered at 6, 12 and 18 hours following the first dose. At time point 24 hours (i.e. the fifth dose of acetaminophen), all subjects will begin to receive 975 mg of oral acetaminophen, continuing every six hours until discharge.
Interventions
Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.
Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
56 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for elective, primary total hip replacement for osteoarthritis * American Society of Anesthesiologists (ASA) Physical Classification I-III * Weight 50 kg or greater * Body mass index 18-40 kg/m2
Exclusion criteria
* Inability to consent to study * Inability to speak English * Pregnancy * Weight \<50 kg * Revision hip replacement or emergency surgery * Contraindications to spinal anesthesia: coagulopathy or bleeding diathesis, local infection, allergy to local anesthetics * Allergies/intolerances/contraindications to any of the multimodal agents: acetaminophen, pregabalin, celecoxib, ketamine, or dexamethasone * Chronic pain from a separate source other than operative hip * Daily opioid equivalent use of 30 mg of morphine or greater at time of consent * History of heart failure * History of drug or alcohol abuse * Rheumatoid arthritis * Uncontrolled anxiety, schizophrenia or other psychiatric disorder that, in the opinion of the investigator, may interfere with the study assessments * Chronic malnutrition, renal or liver impairment * Hypersensitivity to acetaminophen or any of its excipients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24 Hour Opioid Consumption | 24 hours | Cumulative dose of hydromorphone consumed in the first 24 hours postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively) | preoperatively | Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). |
| Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU) | 1 hour after arrival to PACU | Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). |
| Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours) | 8 hours | Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). |
| Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours) | 24 hours | Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). |
| Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours) | 36 hours | Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). |
| Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours) | 48 hours | Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). |
| Subject Satisfaction at 24 Hours | 24 hours | Overall subject satisfaction with hospital experience at the 24 hour time point using a simple 11-point Likert scale to quantify global satisfaction. 0=completely unsatisfied, 10=completely satisfied. |
| Subject Satisfaction at 48 Hours (48 Hours) | 48 hours | Overall subject satisfaction with hospital experience at the 48 hour time point using a simple 11-point Likert scale to quantify global satisfaction. 0=completely unsatisfied, 10=completely satisfied. |
| Straight Leg Raise | Postoperative day 1 | Number of participants who are able to complete the active straight leg test. The subject rests supine and is asked to lift his/her operative lower limb (with knee extended) until the ankle is 20 cm from level. If the subject can do this, the test is positive. |
| Heel Slide Test | Postoperative day 1 | Number of participants who are able to complete the heel-slide test. The subject rests supine and is asked to place the heel of his/her operative side on the contralateral knee, then slide the heel down to the ankle and back in one continuous motion. If the subject can do this, the test is positive. If the subject cannot do this in one motion, or if pain or other factors prevent the test from being performed, the test is negative. |
| Number of Participants Able to Complete the Supine to Sit Test | Postoperative day 1 | Number of participants able to go from supine to a sitting position independently. |
| Self-paced Walk Test | Postoperative day 1 | Time taken to walk down a hallway 20 m at a safe and quick pace, turn around and return to starting point. |
| Number of Participants With Opioid-related Adverse Events | 0-72 hours | Incidence of respiratory desaturation events, nausea, vomiting, pruritis, ileus, and constipation |
| Analgesic Consumption as Measured by Patient Diary | day 30 | morphine equivalent units of oral opioids and other non-opioids |
| Worst Pain (Day 30) | day 30 | Participants are asked to rate their WORST pain on POSTOPERATIVE DAY 30 on an 11-point scale (0=no pain at all, 10=worst imaginable pain). |
| Subject Satisfaction at 48 Hours | 48 hours | Overall subject satisfaction with hospital experience at the 48 hour time point using a simple 11-point Likert scale to quantify global satisfaction. 0=completely unsatisfied, 10=completely satisfied. |
| Opioid Consumption (Other) | 0-48 hours | morphine equivalent units of intravenous and oral opioids |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hospital Length of Stay | 0-72 hours | Time to both discharge readiness and to actual discharge |
| Overall Hospital Admission Costs | 0-72 hours | difference in total hospital admission cost between groups |
| Pharmacy-related Costs | 0-72 hours | difference in pharmacy-related cost between groups |
| Costs Related to Opioid-related Adverse Events | 0-72 hours | difference in cost related to treatment of opioid-related adverse events (nausea, vomiting, pruritis, constipation, respiratory depression, dizziness) between groups |
| Cost Associated With Nursing Interventions and Drugs to Treat Opioid-related Adverse Events | 0-72 hours | mean cost (per patient) related to nursing care of opioid-related adverse events (nausea, vomiting, pruritis, constipation, respiratory depression, dizziness) in $USD |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intravenous Acetaminophen Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.
Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area. | 31 |
| Oral Acetaminophen Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.
Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area. | 29 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 10 | 11 |
Baseline characteristics
| Characteristic | Total | Intravenous Acetaminophen | Oral Acetaminophen |
|---|---|---|---|
| Age, Continuous | 64.5 years | 65 years | 63 years |
| ASA Physical Classification ASA I | 1 Participants | 1 Participants | 0 Participants |
| ASA Physical Classification ASA II | 36 Participants | 17 Participants | 19 Participants |
| ASA Physical Classification ASA III | 23 Participants | 13 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 46 Participants | 23 Participants | 23 Participants |
| Region of Enrollment United States | 60 participants | 31 participants | 29 participants |
| Sex: Female, Male Female | 26 Participants | 10 Participants | 16 Participants |
| Sex: Female, Male Male | 34 Participants | 21 Participants | 13 Participants |
| Weight | 87.63 kilograms STANDARD_DEVIATION 20.29 | 87.99 kilograms STANDARD_DEVIATION 21.9 | 87.25 kilograms STANDARD_DEVIATION 18.79 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 29 |
| other Total, other adverse events | 13 / 31 | 13 / 29 |
| serious Total, serious adverse events | 0 / 31 | 1 / 29 |
Outcome results
Primary
24 Hour Opioid Consumption
Cumulative dose of hydromorphone consumed in the first 24 hours postoperatively
Time frame: 24 hours
Population: Only completed participants are included.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Acetaminophen | 24 Hour Opioid Consumption | 3.0 morphine milliequivalent |
| Oral Acetaminophen | 24 Hour Opioid Consumption | 3.4 morphine milliequivalent |
Secondary
Analgesic Consumption as Measured by Patient Diary
morphine equivalent units of oral opioids and other non-opioids
Time frame: day 30
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Acetaminophen | Analgesic Consumption as Measured by Patient Diary | 0 mg |
| Oral Acetaminophen | Analgesic Consumption as Measured by Patient Diary | 0 mg |
Secondary
Heel Slide Test
Number of participants who are able to complete the heel-slide test. The subject rests supine and is asked to place the heel of his/her operative side on the contralateral knee, then slide the heel down to the ankle and back in one continuous motion. If the subject can do this, the test is positive. If the subject cannot do this in one motion, or if pain or other factors prevent the test from being performed, the test is negative.
Time frame: Postoperative day 1
Population: Only completed participants are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravenous Acetaminophen | Heel Slide Test | 25 Participants |
| Oral Acetaminophen | Heel Slide Test | 16 Participants |
Secondary
Number of Participants Able to Complete the Supine to Sit Test
Number of participants able to go from supine to a sitting position independently.
Time frame: Postoperative day 1
Population: Only completed participants are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravenous Acetaminophen | Number of Participants Able to Complete the Supine to Sit Test | 10 Participants |
| Oral Acetaminophen | Number of Participants Able to Complete the Supine to Sit Test | 6 Participants |
Secondary
Number of Participants With Opioid-related Adverse Events
Incidence of respiratory desaturation events, nausea, vomiting, pruritis, ileus, and constipation
Time frame: 0-72 hours
Population: Only completed participants are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intravenous Acetaminophen | Number of Participants With Opioid-related Adverse Events | 15 participants |
| Oral Acetaminophen | Number of Participants With Opioid-related Adverse Events | 7 participants |
Secondary
Opioid Consumption (Other)
morphine equivalent units of intravenous and oral opioids
Time frame: 0-48 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Acetaminophen | Opioid Consumption (Other) | 6.2 morphine milliequivalent |
| Oral Acetaminophen | Opioid Consumption (Other) | 6.8 morphine milliequivalent |
Secondary
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours)
Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Acetaminophen | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours) | 5.0 score on a scale |
| Oral Acetaminophen | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours) | 4.0 score on a scale |
Secondary
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours)
Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Acetaminophen | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours) | 2.0 score on a scale |
| Oral Acetaminophen | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours) | 1.0 score on a scale |
Secondary
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours)
Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
Time frame: 36 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Acetaminophen | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours) | 5.0 score on a scale |
| Oral Acetaminophen | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours) | 4.5 score on a scale |
Secondary
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours)
Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
Time frame: 36 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Acetaminophen | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours) | 3.0 score on a scale |
| Oral Acetaminophen | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours) | 2.0 score on a scale |
Secondary
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours)
Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
Time frame: 48 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Acetaminophen | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours) | 5.0 score on a scale |
| Oral Acetaminophen | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours) | 5.0 score on a scale |
Secondary
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours)
Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
Time frame: 48 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Acetaminophen | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours) | 2.0 score on a scale |
| Oral Acetaminophen | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours) | 2.0 score on a scale |
Secondary
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours)
Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
Time frame: 8 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Acetaminophen | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours) | 3.0 score on a scale |
| Oral Acetaminophen | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours) | 5.5 score on a scale |
Secondary
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours)
Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
Time frame: 8 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Acetaminophen | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours) | 2.0 score on a scale |
| Oral Acetaminophen | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours) | 3.0 score on a scale |
Secondary
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively)
Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
Time frame: preoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Acetaminophen | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively) | 7.0 score on a scale |
| Oral Acetaminophen | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively) | 7.0 score on a scale |
Secondary
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively)
Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
Time frame: preoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Acetaminophen | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively) | 1.0 score on a scale |
| Oral Acetaminophen | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively) | 2.0 score on a scale |
Secondary
Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU)
Pain scores (using NRS-11 scale) at with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
Time frame: 1 hour after arrival to PACU
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Acetaminophen | Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU) | 2.0 score on a scale |
| Oral Acetaminophen | Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU) | 2.0 score on a scale |
Secondary
Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU)
Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
Time frame: 1 hour after arrival to PACU
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Acetaminophen | Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU) | 1.0 score on a scale |
| Oral Acetaminophen | Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU) | 1.0 score on a scale |
Secondary
Self-paced Walk Test
Time taken to walk down a hallway 20 m at a safe and quick pace, turn around and return to starting point.
Time frame: Postoperative day 1
Population: Only completed participants are included.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intravenous Acetaminophen | Self-paced Walk Test | 86 seconds |
| Oral Acetaminophen | Self-paced Walk Test | 63 seconds |
Secondary
Straight Leg Raise
Number of participants who are able to complete the active straight leg test. The subject rests supine and is asked to lift his/her operative lower limb (with knee extended) until the ankle is 20 cm from level. If the subject can do this, the test is positive.
Time frame: Postoperative day 1
Population: Only completed participants are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravenous Acetaminophen | Straight Leg Raise | 16 Participants |
| Oral Acetaminophen | Straight Leg Raise | 11 Participants |
Secondary
Subject Satisfaction at 24 Hours
Overall subject satisfaction with hospital experience at the 24 hour time point using a simple 11-point Likert scale to quantify global satisfaction. 0=completely unsatisfied, 10=completely satisfied.
Time frame: 24 hours
Population: Only completed participants are included.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Acetaminophen | Subject Satisfaction at 24 Hours | 9 score on a scale |
| Oral Acetaminophen | Subject Satisfaction at 24 Hours | 9 score on a scale |
Secondary
Subject Satisfaction at 48 Hours
Overall subject satisfaction with hospital experience at the 48 hour time point using a simple 11-point Likert scale to quantify global satisfaction. 0=completely unsatisfied, 10=completely satisfied.
Time frame: 48 hours
Population: Only completed participants are included.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Acetaminophen | Subject Satisfaction at 48 Hours | 9 score on a scale |
| Oral Acetaminophen | Subject Satisfaction at 48 Hours | 9 score on a scale |
Secondary
Subject Satisfaction at 48 Hours (48 Hours)
Overall subject satisfaction with hospital experience at the 48 hour time point using a simple 11-point Likert scale to quantify global satisfaction. 0=completely unsatisfied, 10=completely satisfied.
Time frame: 48 hours
Population: Only completed participants are included.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Acetaminophen | Subject Satisfaction at 48 Hours (48 Hours) | 9 score on a scale |
| Oral Acetaminophen | Subject Satisfaction at 48 Hours (48 Hours) | 9 score on a scale |
Secondary
Worst Pain (Day 30)
Participants are asked to rate their WORST pain on POSTOPERATIVE DAY 30 on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
Time frame: day 30
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Acetaminophen | Worst Pain (Day 30) | 1.0 score on a scale |
| Oral Acetaminophen | Worst Pain (Day 30) | 0 score on a scale |
Other Pre-specified
Cost Associated With Nursing Interventions and Drugs to Treat Opioid-related Adverse Events
mean cost (per patient) related to nursing care of opioid-related adverse events (nausea, vomiting, pruritis, constipation, respiratory depression, dizziness) in $USD
Time frame: 0-72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Acetaminophen | Cost Associated With Nursing Interventions and Drugs to Treat Opioid-related Adverse Events | 1.86 US dollars | Standard Deviation 2.68 |
| Oral Acetaminophen | Cost Associated With Nursing Interventions and Drugs to Treat Opioid-related Adverse Events | 1.82 US dollars | Standard Deviation 3.5 |
Other Pre-specified
Costs Related to Opioid-related Adverse Events
difference in cost related to treatment of opioid-related adverse events (nausea, vomiting, pruritis, constipation, respiratory depression, dizziness) between groups
Time frame: 0-72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Acetaminophen | Costs Related to Opioid-related Adverse Events | 0.80 US dollars | Standard Deviation 1.18 |
| Oral Acetaminophen | Costs Related to Opioid-related Adverse Events | 0.85 US dollars | Standard Deviation 1.73 |
Other Pre-specified
Hospital Length of Stay
Time to both discharge readiness and to actual discharge
Time frame: 0-72 hours
Population: Only completed participants are included.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Acetaminophen | Hospital Length of Stay | 1 days |
| Oral Acetaminophen | Hospital Length of Stay | 1 days |
Other Pre-specified
Overall Hospital Admission Costs
difference in total hospital admission cost between groups
Time frame: 0-72 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Acetaminophen | Overall Hospital Admission Costs | 14682 US dollars |
| Oral Acetaminophen | Overall Hospital Admission Costs | 14782 US dollars |
Other Pre-specified
Pharmacy-related Costs
difference in pharmacy-related cost between groups
Time frame: 0-72 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Acetaminophen | Pharmacy-related Costs | 498 US dollars |
| Oral Acetaminophen | Pharmacy-related Costs | 510 US dollars |