Multimodal Analgesia With Acetaminophen vs. Narcotics Alone After Hip Arthroscopy

Hip Arthroscopy Clinical Trial

Official title:

Multimodal Analgesia With Acetaminophen vs. Narcotics Alone After Hip Arthroscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03510910
• Other study ID #: 18-00167
• Status: Completed
• Phase: Phase 4
• Start date: April 10, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Arthroscopy

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Morphine-equivalent Consumption	Amount of oxycodone/acetaminophen (Percocet) in 5mg/325mg doses will be recorded in number of pills	7 days post-surgery
Primary	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
Primary	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
Primary	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