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Completed

NCT Number: NCT03510910

Multimodal Analgesia With Acetaminophen vs. Narcotics Alone After Hip Arthroscopy

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.

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Key information

Conditions

Hip Arthroscopy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetaminophen

Drug

acetaminophen 600 mg to be taken every 8 hours (TID)

Percocet

Drug

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 27, 2018
Registry last updated
Jan 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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