CompletedNCT02839876Updated Mar 9, 2021Results posted

Intravenous Versus Oral Acetaminophen in Primary Total Hip Arthroplasty

A Phase 4 interventional study of Intravenous acetaminophen and Oral acetaminophen in Osteoarthritis, Acetaminophen and Arthroplasty, Hip Replacement, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 56 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-03-09.

Sponsored by Duke University · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 81
Allocation: Randomized
Ages: 56 Years to 85 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Osteoarthritis
Acetaminophen
Arthroplasty, Hip Replacement

Browse trials for

Osteoarthritis 4,399

In context

Osteoarthritis

4,399 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.

This study's enrollment of 81 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

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Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 56 Years to 85 Years
Sexes eligible: All
Accepts 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

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

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 81 participants (actual)

Study arms

Experimental
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.
Drug: Intravenous acetaminophen
Active comparator
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.
Drug: Oral acetaminophen

Interventions

DrugIntravenous acetaminophen
Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.
Also known as: Ofirmev
DrugOral acetaminophen
Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

What researchers measure

Primary outcomes

24 Hour Opioid Consumption
Cumulative dose of hydromorphone consumed in the first 24 hours postoperatively
Time frame: 24 hours

Secondary outcomes

Opioid Consumption (Other)
morphine equivalent units of intravenous and oral opioids
Time frame: 0-48 hours
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
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
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
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
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
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
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
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
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
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
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
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
Number of Participants With Opioid-related Adverse Events
Incidence of respiratory desaturation events, nausea, vomiting, pruritis, ileus, and constipation
Time frame: 0-72 hours
Analgesic Consumption as Measured by Patient Diary
morphine equivalent units of oral opioids and other non-opioids
Time frame: day 30
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
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
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
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
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
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
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
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

Other outcomes

Hospital Length of Stay
Time to both discharge readiness and to actual discharge
Time frame: 0-72 hours
Overall Hospital Admission Costs
difference in total hospital admission cost between groups
Time frame: 0-72 hours
Pharmacy-related Costs
difference in pharmacy-related cost between groups
Time frame: 0-72 hours
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
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

Results

Posted Jan 18, 2020

Participant flow

Participant flow — Overall Study
Milestone	Intravenous Acetaminophen	Oral Acetaminophen
Started	41	40
Completed	31	29
Not completed	10	11
Withdrew: Protocol violation	10	11

Outcome measures

Primary24 Hour Opioid Consumption

Cumulative dose of hydromorphone consumed in the first 24 hours postoperatively

Time frame:: 24 hours
Reported as:: Median · morphine milliequivalent

24 Hour Opioid Consumption
morphine milliequivalent	Intravenous Acetaminophen	Oral Acetaminophen
24 Hour Opioid Consumption	3.0 (1.9 to 6.0)	3.4 (2.0 to 5.9)

SecondaryOpioid Consumption (Other)

morphine equivalent units of intravenous and oral opioids

Time frame:: 0-48 hours
Reported as:: Median · morphine milliequivalent

Opioid Consumption (Other)
morphine milliequivalent	Intravenous Acetaminophen	Oral Acetaminophen
Opioid Consumption (Other)	6.2 (3.0 to 12.1)	6.8 (3.9 to 11.7)

SecondaryPain 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
Reported as:: Median · score on a scale

Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively)
score on a scale	Intravenous Acetaminophen	Oral Acetaminophen
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively)	7.0 (5.0 to 8.0)	7.0 (6.0 to 8.0)

SecondaryPain 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
Reported as:: Median · score on a scale

Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU)
score on a scale	Intravenous Acetaminophen	Oral Acetaminophen
Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU)	1.0 (0.0 to 3.75)	1.0 (0.0 to 3.0)

SecondaryPain 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
Reported as:: Median · score on a scale

Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours)
score on a scale	Intravenous Acetaminophen	Oral Acetaminophen
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours)	2.0 (0.0 to 4.75)	3.0 (0.0 to 5.0)

SecondaryPain 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
Reported as:: Median · score on a scale

Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours)
score on a scale	Intravenous Acetaminophen	Oral Acetaminophen
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours)	2.0 (1.0 to 3.5)	1.0 (0.0 to 3.0)

SecondaryPain 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
Reported as:: Median · score on a scale

Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours)
score on a scale	Intravenous Acetaminophen	Oral Acetaminophen
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours)	3.0 (1.0 to 4.0)	2.0 (0.75 to 3.0)

SecondaryPain 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
Reported as:: Median · score on a scale

Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours)
score on a scale	Intravenous Acetaminophen	Oral Acetaminophen
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours)	2.0 (1.0 to 3.0)	2.0 (0.0 to 3.0)

SecondarySubject 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
Reported as:: Median · score on a scale

Subject Satisfaction at 24 Hours
score on a scale	Intravenous Acetaminophen	Oral Acetaminophen
Subject Satisfaction at 24 Hours	9 (8 to 10)	9 (8 to 10)

SecondarySubject 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
Reported as:: Median · score on a scale

Subject Satisfaction at 48 Hours (48 Hours)
score on a scale	Intravenous Acetaminophen	Oral Acetaminophen
Subject Satisfaction at 48 Hours (48 Hours)	9 (8 to 10)	9 (9 to 10)

SecondaryStraight 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
Reported as:: Count of participants · Participants

Straight Leg Raise
Participants	Intravenous Acetaminophen	Oral Acetaminophen
Straight Leg Raise	16	11

SecondaryHeel 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
Reported as:: Count of participants · Participants

Heel Slide Test
Participants	Intravenous Acetaminophen	Oral Acetaminophen
Heel Slide Test	25	16

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants Able to Complete the Supine to Sit Test
Participants	Intravenous Acetaminophen	Oral Acetaminophen
Number of Participants Able to Complete the Supine to Sit Test	10	6

SecondarySelf-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
Reported as:: Mean · seconds

Self-paced Walk Test
seconds	Intravenous Acetaminophen	Oral Acetaminophen
Self-paced Walk Test	86 (41 to 1641)	63 (43 to 1328)

SecondaryNumber of Participants With Opioid-related Adverse Events

Incidence of respiratory desaturation events, nausea, vomiting, pruritis, ileus, and constipation

Time frame:: 0-72 hours
Reported as:: Number · participants

Number of Participants With Opioid-related Adverse Events
participants	Intravenous Acetaminophen	Oral Acetaminophen
Number of Participants With Opioid-related Adverse Events	15	7

SecondaryAnalgesic Consumption as Measured by Patient Diary

morphine equivalent units of oral opioids and other non-opioids

Time frame:: day 30
Reported as:: Median · mg

Analgesic Consumption as Measured by Patient Diary
mg	Intravenous Acetaminophen	Oral Acetaminophen
Analgesic Consumption as Measured by Patient Diary	0 (0 to 0)	0 (0 to 0)

SecondaryWorst 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
Reported as:: Median · score on a scale

Worst Pain (Day 30)
score on a scale	Intravenous Acetaminophen	Oral Acetaminophen
Worst Pain (Day 30)	1.0 (0.0 to 2)	0 (0 to 3)

SecondaryPain 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
Reported as:: Median · score on a scale

Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively)
score on a scale	Intravenous Acetaminophen	Oral Acetaminophen
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively)	1.0 (0.0 to 4.0)	2.0 (0.0 to 5.0)

SecondaryPain 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
Reported as:: Median · score on a scale

Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU)
score on a scale	Intravenous Acetaminophen	Oral Acetaminophen
Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU)	2.0 (0.0 to 4.75)	2.0 (0.0 to 4.0)

SecondaryPain 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
Reported as:: Median · score on a scale

Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours)
score on a scale	Intravenous Acetaminophen	Oral Acetaminophen
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours)	3.0 (1.0 to 5.0)	5.5 (3.75 to 7.25)

SecondaryPain 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
Reported as:: Median · score on a scale

Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours)
score on a scale	Intravenous Acetaminophen	Oral Acetaminophen
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours)	5.0 (3.0 to 7.5)	4.0 (3.0 to 7.0)

SecondaryPain 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
Reported as:: Median · score on a scale

Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours)
score on a scale	Intravenous Acetaminophen	Oral Acetaminophen
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours)	5.0 (3.0 to 70)	4.5 (3.75 to 6.0)

SecondarySubject Satisfaction at 48 Hours

Time frame:: 48 hours
Reported as:: Median · score on a scale

Subject Satisfaction at 48 Hours
score on a scale	Intravenous Acetaminophen	Oral Acetaminophen
Subject Satisfaction at 48 Hours	9 (8 to 10)	9 (9 to 10)

SecondaryPain 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
Reported as:: Median · score on a scale

Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours)
score on a scale	Intravenous Acetaminophen	Oral Acetaminophen
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours)	5.0 (3.0 to 6.0)	5.0 (2.5 to 6.0)

Other pre-specifiedHospital Length of Stay

Time to both discharge readiness and to actual discharge

Time frame:: 0-72 hours
Reported as:: Median · days

Hospital Length of Stay
days	Intravenous Acetaminophen	Oral Acetaminophen
Hospital Length of Stay	1 (1 to 2)	1 (1 to 2)

Other pre-specifiedOverall Hospital Admission Costs

difference in total hospital admission cost between groups

Time frame:: 0-72 hours
Reported as:: Median · US dollars

Overall Hospital Admission Costs
US dollars	Intravenous Acetaminophen	Oral Acetaminophen
Overall Hospital Admission Costs	14682 (13468 to 16353)	14782 (13461 to 17013)

Other pre-specifiedPharmacy-related Costs

difference in pharmacy-related cost between groups

Time frame:: 0-72 hours
Reported as:: Median · US dollars

Pharmacy-related Costs
US dollars	Intravenous Acetaminophen	Oral Acetaminophen
Pharmacy-related Costs	498 (465 to 518)	510 (459 to 539)

Other pre-specifiedCosts 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
Reported as:: Mean · US dollars

Costs Related to Opioid-related Adverse Events
US dollars	Intravenous Acetaminophen	Oral Acetaminophen
Costs Related to Opioid-related Adverse Events	0.80 ± 1.18	0.85 ± 1.73

Other pre-specifiedCost 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
Reported as:: Mean · US dollars

Cost Associated With Nursing Interventions and Drugs to Treat Opioid-related Adverse Events
US dollars	Intravenous Acetaminophen	Oral Acetaminophen
Cost Associated With Nursing Interventions and Drugs to Treat Opioid-related Adverse Events	1.86 ± 2.68	1.82 ± 3.50

Adverse events

Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Intravenous Acetaminophen	0/31 (0%)	0/31 (0%)	13/31 (41.9%)
Oral Acetaminophen	0/29 (0%)	1/29 (3.4%)	13/29 (44.8%)

Most frequent serious events

Most frequent serious events
Event	Intravenous Acetaminophen	Oral Acetaminophen
Postoperative hematomaSurgical and medical procedures	0/31	1/29

Most frequent other events

Most frequent other events
Event	Intravenous Acetaminophen	Oral Acetaminophen
NauseaGastrointestinal disorders	9/31	3/29
Dizziness/orthostasisCardiac disorders	7/31	1/29
constipationGastrointestinal disorders	3/31	4/29
wound erythema/drainageInfections and infestations	1/31	3/29
PruritisSkin and subcutaneous tissue disorders	2/31	0/29
Hip dislocationMusculoskeletal and connective tissue disorders	0/31	1/29
Polyneuropathy, peripheralNervous system disorders	0/31	1/29
Abnormal lab values (INR)Investigations	1/31	0/29
FeverInfections and infestations	1/31	0/29

Baseline characteristics

Only completed participants are included.

Age, Continuous
Age, Continuous(years)	Intravenous Acetaminophen	Oral Acetaminophen	Total
Mean	65 (61 to 71)	63 (59 to 67)	64.5 (60.5 to 70.5)

Sex: Female, Male
Sex: Female, Male(Participants)	Intravenous Acetaminophen	Oral Acetaminophen	Total
Female	10	16	26
Male	21	13	34

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Intravenous Acetaminophen	Oral Acetaminophen	Total
American Indian or Alaska Native	1	0	1
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	1	5	6
White	23	23	46
More than one race	5	1	6
Unknown or Not Reported	1	0	1

Region of Enrollment
Region of Enrollment(participants)	Intravenous Acetaminophen	Oral Acetaminophen	Total
United States	31	29	60

ASA Physical Classification
ASA Physical Classification(Participants)	Intravenous Acetaminophen	Oral Acetaminophen	Total
ASA I	1	0	1
ASA II	17	19	36
ASA III	13	10	23

Weight
Weight(kilograms)	Intravenous Acetaminophen	Oral Acetaminophen	Total
Mean	87.99 ± 21.90	87.25 ± 18.79	87.63 ± 20.29

Study locations

1 site

Duke University Hospital
Durham, North Carolina 27710, United States

References and documents

Study documents

Protocol and statistical analysis plan · Dec 6, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02839876
Lead sponsor: Duke University
Responsible party: Sponsor
First posted: Jul 21, 2016
Start date: Mar 14, 2017
Primary completion: Oct 2, 2018
Completion: Oct 31, 2018
Results posted: Jan 18, 2020
Last update: Mar 9, 2021

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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