Multimodal Analgesia With Acetaminophen vs. Narcotics Alone After Hip Arthroscopy

NCT03510910 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 18-00167
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Arthroscopy

Outcome Measures

Primary Outcomes (5)

• Patient Satisfaction

  Satisfaction was reported on a Likert-type scale of 1-10 (the higher the score, the higher the satisfaction)

  7 days post-surgery

• Morphine-equivalent Consumption

  Amount of oxycodone/acetaminophen (Percocet) in 5mg/325mg doses will be recorded in number of pills

  7 days post-surgery

• Score on Visual Analog Scale (VAS) of Pain

  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.

  24 hours post-surgery

• Score on Visual Analog Scale (VAS) of Pain

  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 days post-surgery

• Score on Visual Analog Scale (VAS) of Pain

  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.

  7 days post-surgery

Study Arms (2)

Acetaminophen along with a reduced quantity of Percocet

EXPERIMENTAL

Drug: Acetaminophen; Drug: Percocet

Percocet only

EXPERIMENTAL

Drug: Percocet

Interventions

Acetaminophen DRUG

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

Acetaminophen along with a reduced quantity of Percocet

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

Acetaminophen along with a reduced quantity of Percocet; Percocet only

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Acetaminophen; oxycodone-acetaminophen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Thomas Youm, MD
• Organization: NYU Langone Health

Thomas.Youm@nyulangone.org

212-348-3636

Study Officials

• Thomas Youm, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: April 27, 2018
• Study Start: April 10, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 7, 2021
• Results First Posted: January 7, 2021

Record last verified: 2020-12

Locations

US (1)