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Trial record 3 of 57 for:    Recruiting, Not yet recruiting, Available Studies | Arthroscopy

Multimodal Analgesia With Acetaminophen vs. Narcotics Alone After Hip Arthroscopy

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ClinicalTrials.gov Identifier: NCT03510910
Recruitment Status : Recruiting
First Posted : April 27, 2018
Last Update Posted : May 10, 2019
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)
Estimated 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
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

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. 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.



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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


Contacts
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Contact: Hien Pham 212 348 3636 Hien.Pham@nyumc.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Hien Pham    212-348-3636    hien.pham@nyumc.org   
Principal Investigator: Thomas Youm, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Thomas Youm, MD NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03510910     History of Changes
Other Study ID Numbers: 18-00167
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019

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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
Acetaminophen, hydrocodone drug combination
Oxycodone
Narcotics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Central Nervous System Depressants
Analgesics, Opioid
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents