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Trial record 1 of 1 for:    NCT02839876
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Intravenous Versus Oral Acetaminophen in Primary Total Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT02839876
Recruitment Status : Completed
First Posted : July 21, 2016
Results First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Acetaminophen Arthroplasty, Hip Replacement Drug: Intravenous acetaminophen Drug: Oral acetaminophen Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 14, 2017
Actual Primary Completion Date : October 2, 2018
Actual Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.
Other Name: Ofirmev

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
Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.




Primary Outcome Measures :
  1. 24 Hour Opioid Consumption [ Time Frame: 24 hours ]
    Cumulative dose of hydromorphone consumed in the first 24 hours postoperatively


Secondary Outcome Measures :
  1. Opioid Consumption (Other) [ Time Frame: 0-48 hours ]
    morphine equivalent units of intravenous and oral opioids

  2. Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively) [ Time Frame: 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).

  3. 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 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).

  4. Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours) [ Time Frame: 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).

  5. Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours) [ Time Frame: 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).

  6. Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours) [ Time Frame: 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).

  7. Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours) [ Time Frame: 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).

  8. Subject Satisfaction at 24 Hours [ Time Frame: 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.

  9. Subject Satisfaction at 48 Hours (48 Hours) [ Time Frame: 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.

  10. Straight Leg Raise [ Time Frame: 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.

  11. Heel Slide Test [ Time Frame: 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.

  12. Number of Participants Able to Complete the Supine to Sit Test [ Time Frame: Postoperative day 1 ]
    Number of participants able to go from supine to a sitting position independently.

  13. Self-paced Walk Test [ Time Frame: 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.

  14. Number of Participants With Opioid-related Adverse Events [ Time Frame: 0-72 hours ]
    Incidence of respiratory desaturation events, nausea, vomiting, pruritis, ileus, and constipation

  15. Analgesic Consumption as Measured by Patient Diary [ Time Frame: day 30 ]
    morphine equivalent units of oral opioids and other non-opioids

  16. Worst Pain (Day 30) [ Time Frame: 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).

  17. Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively) [ Time Frame: 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).

  18. 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 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).

  19. Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours) [ Time Frame: 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).

  20. Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours) [ Time Frame: 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).

  21. Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours) [ Time Frame: 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).

  22. Subject Satisfaction at 48 Hours [ Time Frame: 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.

  23. Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours) [ Time Frame: 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).


Other Outcome Measures:
  1. Hospital Length of Stay [ Time Frame: 0-72 hours ]
    Time to both discharge readiness and to actual discharge

  2. Overall Hospital Admission Costs [ Time Frame: 0-72 hours ]
    difference in total hospital admission cost between groups

  3. Pharmacy-related Costs [ Time Frame: 0-72 hours ]
    difference in pharmacy-related cost between groups

  4. Costs Related to Opioid-related Adverse Events [ Time Frame: 0-72 hours ]
    difference in cost related to treatment of opioid-related adverse events (nausea, vomiting, pruritis, constipation, respiratory depression, dizziness) between groups

  5. Cost Associated With Nursing Interventions and Drugs to Treat Opioid-related Adverse Events [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   56 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02839876


Locations
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United States, North Carolina
Duke University Hospital
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
  Study Documents (Full-Text)

Documents provided by Duke University:

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02839876    
Other Study ID Numbers: Pro00072610
First Posted: July 21, 2016    Key Record Dates
Results First Posted: January 18, 2020
Last Update Posted: January 18, 2020
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics