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IV vs. Oral Acetaminophen as a Component of Multimodal Analgesia After Total Hip Arthroplasty (IV Tylenol)

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ClinicalTrials.gov Identifier: NCT03020966
Recruitment Status : Recruiting
First Posted : January 13, 2017
Last Update Posted : October 24, 2018
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Description
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Brief Summary:
The purpose of this study is to determine how well two different methods of administrating Tylenol reduce pain and improve patient satisfaction after total hip replacement (THR) surgery. The methods of administration are orally, via a pill that is to be swallowed, and intravenously. Our aim is to determine whether oral or intravenous administration of Tylenol will reduce opioid consumption and opioid-related side effects after THR.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Opioid Use Drug: Acetaminophen Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: IV vs. Oral Acetaminophen as a Component of Multimodal Analgesia After Total Hip Arthroplasty: a Randomized, Blinded Trial
Actual Study Start Date : February 16, 2017
Estimated Primary Completion Date : June 16, 2019
Estimated Study Completion Date : June 16, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Oral Tylenol
Patient group receiving 1000mg of oral acetaminophen and an intravenous placebo
 Drug: Acetaminophen
Oral acetaminophen, intravenous placebo
Experimental: Intravenous Tylenol
Patient group receiving 1000mg of intravenous acetaminophen and an oral placebo
 Drug: Acetaminophen
Intravenous acetaminophen, oral placebo


Outcome Measures
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Primary Outcome Measures :
  1. Pain with physical therapy on post-operative day 1 [ Time Frame: Post operative day 1 ]
    NRS questionnaire

  2. Opioid Use [ Time Frame: Day of surgery to post-operative day 3 ]
    oral morphine equivalents, cumulative, POD 0-3. Recorded in Medication Usage Database

  3. Opioid side effects [ Time Frame: Post-operative day 1 ]
    Opioid related symptom distress scale, ORSDS, composite score POD1


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Adult
  • Scheduled for an elective primary THA with a participating surgeon,
  • Planned for Combined Spinal Epidural anesthesia (CSE) and Patient Controlled Epidural Analgesia (PCEA)
  • English-speaking
  • Patients that did not receive pre-operative opioids

Exclusion criteria:

  • Hepatic or renal insufficiency, as defined by abnormal readings on liver and kidney functioning tests.
  • Hypersensitivity or contraindication to protocol medication
  • Contraindication for CSE and PCEA
  • Incapable to provide consent/answer questions in English
  • Revision or urgent surgery
  • Receiving Periarticular Injections
  • History of opioid use
  • Patients on disability or worker's compensation
Contacts and Locations
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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): NCT03020966


Contacts
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Contact: George A Birch, BS 2127747377 birchg@hss.edu
Contact: Ahava Muskat, BS 2126061510 muskata@hss.edu

Locations
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United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: George A Birch, BS    212-774-7377    birchg@hss.edu   
Contact: Ahava Muskat, BS    2126061510    muskata@hss.edu   
Principal Investigator: Jacques YaDeau, MD, PhD         
Principal Investigator: Geoffrey H Westrich, MD         
Sponsors and Collaborators
Hospital for Special Surgery, New York
Mallinckrodt
Investigators
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Principal Investigator: Jacques Ya Deau, MD, PhD Hospital for Special Surgery, New York
More Information
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Publications:

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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT03020966     History of Changes
Other Study ID Numbers: 2016-209
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018

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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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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics