Multimodal Analgesia With Acetaminophen vs. Narcotics Alone After Hip Arthroscopy
NCT ID: NCT03510910
Last Updated: 2021-01-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2018-04-10
2019-12-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Acetaminophen along with a reduced quantity of Percocet
Acetaminophen
acetaminophen 600 mg to be taken every 8 hours (TID)
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
Percocet only
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
Interventions
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Acetaminophen
acetaminophen 600 mg to be taken every 8 hours (TID)
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
Eligibility Criteria
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Inclusion Criteria
* Patients indicated and scheduled for arthroscopic hip surgery
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Thomas Youm, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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New York University School of Medicine
New York, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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18-00167
Identifier Type: -
Identifier Source: org_study_id
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