OsteoarthritisPhase 4NCT02839876
Intravenous Versus Oral Acetaminophen in Primary Total Hip Arthroplasty
A Phase 4 study testing Intravenous acetaminophen and Oral acetaminophen in people with Osteoarthritis and Acetaminophen, run by Duke University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 56 to 85 years
- Conditions the study is for
- Osteoarthritis, Acetaminophen, Arthroplasty, Hip Replacement
- What is being tested?
- Intravenous acetaminophen and Oral acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2017to 31 Oct 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 56 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27710
About this study
Official title: Comparison of Multimodal Analgesic Regimen With Intravenous Acetaminophen to Standard Oral Multimodal Therapy in Primary Total Hip Arthroplasty: A Randomized Controlled Double Blind Trial
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:
- 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.
- 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.
- 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
- Osteoarthritis, Acetaminophen, Arthroplasty, Hip Replacement
- Being tested
- Intravenous acetaminophen, Oral acetaminophen
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous acetaminophenDrug
Also called Ofirmev
Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.
Oral acetaminophenDrug
Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous acetaminophen | Experimental | 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. Receives: Drug: Intravenous acetaminophen |
| Oral acetaminophen | Active comparator | 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. Receives: Drug: Oral acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 Hour Opioid Consumption
Cumulative dose of hydromorphone consumed in the first 24 hours postoperatively
Measured: 24 hours
Secondary outcomes (23)
Opioid Consumption (Other)
morphine equivalent units of intravenous and oral opioids
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Postoperative day 1
Number of Participants With Opioid-related Adverse Events
Incidence of respiratory desaturation events, nausea, vomiting, pruritis, ileus, and constipation
Measured: 0-72 hours
Analgesic Consumption as Measured by Patient Diary
morphine equivalent units of oral opioids and other non-opioids
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start14 Mar 2017
- Primary completion2 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839876
- Sponsor's protocol ID
- Pro00072610
- Status last verified
- Mar 2021
- First submitted
- 19 Jul 2016
- Last updated
- 9 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Multimodal Analgesic Regimen With Intravenous Acetaminophen to Standard Oral Multimodal Therapy in Primary Total Hip Arthroplasty: A Randomized Controlled Double Blind Trial
- ClinicalTrials.gov ID
- NCT02839876
- Acronym / sponsor ID
- Pro00072610
- Conditions
- Osteoarthritis, Acetaminophen, Arthroplasty, Hip Replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 2 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Posted 18 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous acetaminophen | Experimental | Drug: Intravenous acetaminophenSubjects 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. |
| Oral acetaminophen | Active comparator | Drug: Oral acetaminophenSubjects 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. |
Who may qualify
- Ages
- 56 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- Inability to consent to study
- Inability to speak English
- Pregnancy
- Weight <50 kg
- Revision hip replacement or emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous acetaminophenAlso: OfirmevSubject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area. | Drug | Intravenous acetaminophen |
| Oral acetaminophenSubject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area. | Drug | Oral acetaminophen |
Primary outcome
24 Hour Opioid Consumption
Time frame: 24 hours
Cumulative dose of hydromorphone consumed in the first 24 hours postoperatively
23 secondary outcomes
Opioid Consumption (Other)
Time frame: 0-48 hours
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively)
Time frame: preoperatively
Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU)
Time frame: 1 hour after arrival to PACU
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours)
Time frame: 8 hours
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours)
Time frame: 24 hours
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours)
Time frame: 36 hours
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours)
Time frame: 48 hours
Subject Satisfaction at 24 Hours
Time frame: 24 hours
Subject Satisfaction at 48 Hours (48 Hours)
Time frame: 48 hours
Straight Leg Raise
Time frame: Postoperative day 1
Heel Slide Test
Time frame: Postoperative day 1
Number of Participants Able to Complete the Supine to Sit Test
Time frame: Postoperative day 1
Self-paced Walk Test
Time frame: Postoperative day 1
Number of Participants With Opioid-related Adverse Events
Time frame: 0-72 hours
Analgesic Consumption as Measured by Patient Diary
Time frame: day 30
Worst Pain (Day 30)
Time frame: day 30
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively)
Time frame: preoperatively
Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU)
Time frame: 1 hour after arrival to PACU
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours)
Time frame: 8 hours
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours)
Time frame: 24 hours
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours)
Time frame: 36 hours
Subject Satisfaction at 48 Hours
Time frame: 48 hours
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours)
Time frame: 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous acetaminophen and Oral acetaminophen in people with Osteoarthritis and Acetaminophen, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 Hour Opioid Consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.