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Multimodal Analgesia With Acetaminophen vs. Narcotics Alone After Hip Arthroscopy

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ClinicalTrials.gov Identifier: NCT03510910
Recruitment Status : Completed
First Posted : April 27, 2018
Results First Posted : January 7, 2021
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:

The purpose of this proposed study is to evaluate the efficacy of a multimodal approach to analgesia for patient's pain after hip arthroscopy and to also assess if this new approach will result in a reduction in post-operative narcotic use.

This study is a single-center, randomized prospective study comparing post-operative pain scores and narcotic consumption between individuals receiving acetaminophen along with a reduced quantity of Percocet (to be used as needed for breakthrough pain) and individuals receiving Percocet only. Both pain management options are considered to be standard of care. Both cohorts will receive aspirin for DVT prophylaxis and celecoxib for heterotopic ossification prophylaxis.

The primary objective of the study are to compare patients' narcotic consumption and reported pain following arthroscopic hip surgery, and determine if acetaminophen can provide adequate pain relief compared to a narcotic medication.


Condition or disease Intervention/treatment Phase
Hip Arthroscopy Drug: Acetaminophen Drug: Percocet Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multimodal Analgesia With Acetaminophen vs. Narcotics Alone After Hip Arthroscopy
Actual Study Start Date : April 10, 2018
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acetaminophen along with a reduced quantity of Percocet Drug: Acetaminophen
acetaminophen 600 mg to be taken every 8 hours (TID)

Drug: Percocet

Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group.

Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN


Experimental: Percocet only Drug: Percocet

Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group.

Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN





Primary Outcome Measures :
  1. Patient Satisfaction [ Time Frame: 7 days post-surgery ]
    Satisfaction was reported on a Likert-type scale of 1-10 (the higher the score, the higher the satisfaction)

  2. Morphine-equivalent Consumption [ Time Frame: 7 days post-surgery ]
    Amount of oxycodone/acetaminophen (Percocet) in 5mg/325mg doses will be recorded in number of pills

  3. Score on Visual Analog Scale (VAS) of Pain [ Time Frame: 24 hours post-surgery ]
    Pain severity scores at rest will be assessed by use of VAS. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The higher the score, the worse the pain.

  4. Score on Visual Analog Scale (VAS) of Pain [ Time Frame: 4 days post-surgery ]
    Pain severity scores at rest will be assessed by use of VAS. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The higher the score, the worse the pain.

  5. Score on Visual Analog Scale (VAS) of Pain [ Time Frame: 7 days post-surgery ]
    Pain severity scores at rest will be assessed by use of VAS. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The higher the score, the worse the pain.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA class I-II
  • Patients indicated and scheduled for arthroscopic hip surgery

Exclusion Criteria:

  • Contraindication to acetaminophen or oxycodone/acetaminophen (e.g. hypersensitivity, history of GI or bleeding disorder)
  • Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)
  • Younger than 18 years of age or older than 65
  • Any patient considered a vulnerable subject
  • Patients on pain medication prior to surgery

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): NCT03510910


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Thomas Youm, MD NYU Langone Health
  Study Documents (Full-Text)

Documents provided by NYU Langone Health:
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03510910    
Other Study ID Numbers: 18-00167
First Posted: April 27, 2018    Key Record Dates
Results First Posted: January 7, 2021
Last Update Posted: January 7, 2021
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics