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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03020966
Recruitment Status : Completed
First Posted : January 13, 2017
Results First Posted : August 10, 2021
Last Update Posted : August 10, 2021
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)
Actual 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
Actual Primary Completion Date : June 16, 2019
Actual 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: 24 hours after the operation (post-operative day 1) ]
    Numerical rating scale of pain on a scale of 0-10, with 0 representing the minimum value of no pain and 10, representing the maximum, defined as being pain as bad as imaginable.

  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: 24 hours after surgery (Post-operative day 1) ]
    The Opioid-Related Symptom Distress Scale (ORSDS) is a Likert scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 symptoms. Frequency is rated on a 4-point scale (1= 'Rarely', 4= 'Almost constantly'). Severity is rated on a 4-point scale (1= 'Slightly', 4= 'Very'). Bothersomeness is rated on a 5-point scale (0.8= 'Not at all', 4.0= 'Very much'). The symptom-specific ORSDS is the average of the 3 symptom distress dimensions. The composite ORSDS score is the average of 12 symptom-specific scores.


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


Locations
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United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
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
  Study Documents (Full-Text)

Documents provided by Hospital for Special Surgery, New York:
Study Protocol and Statistical Analysis Plan  [PDF] March 28, 2016

More Information
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Publications:

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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT03020966    
Other Study ID Numbers: 2016-209
First Posted: January 13, 2017    Key Record Dates
Results First Posted: August 10, 2021
Last Update Posted: August 10, 2021
Last Verified: August 2021

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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
Acetaminophen
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics