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Multimodal Analgesia With Acetaminophen vs. Narcotics Alone After Hip Arthroscopy

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: 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

Tracking Information
First Submitted Date  ICMJE April 18, 2018
First Posted Date  ICMJE April 27, 2018
Results First Submitted Date  ICMJE December 11, 2020
Results First Posted Date  ICMJE January 7, 2021
Last Update Posted Date January 7, 2021
Actual Study Start Date  ICMJE April 10, 2018
Actual Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2020)
  • 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)
  • 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
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 18, 2018)
compare patients' narcotic consumption and reported pain (using VAS) following arthroscopic hip surgery. [ Time Frame: 7 Days ]
Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0=no pain, 10 = worst pain imaginable) at 0.5, 1, 1.5, 2, 4, 6, 24, and 48 hours as well as 7 days after surgery.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multimodal Analgesia With Acetaminophen vs. Narcotics Alone After Hip Arthroscopy
Official Title  ICMJE Multimodal Analgesia With Acetaminophen vs. Narcotics Alone After Hip Arthroscopy
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hip Arthroscopy
Intervention  ICMJE
  • 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

Study Arms  ICMJE
  • Experimental: Acetaminophen along with a reduced quantity of Percocet
    Interventions:
    • Drug: Acetaminophen
    • Drug: Percocet
  • Experimental: Percocet only
    Intervention: Drug: Percocet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 1, 2019
Actual Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03510910
Other Study ID Numbers  ICMJE 18-00167
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas Youm, MD NYU Langone Health
PRS Account NYU Langone Health
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP