Multimodal Analgesia With NSAID vs. Narcotics Alone After Shoulder Instability Surgery

Completed

• Conditions: Shoulder Pain
• Interventions: Other: Oxycodone/acetaminophen (Percocet) 5 mg/325; Other: ibuprofen 600 mg

• Registration Number: NCT04018768
• Lead Sponsor: NYU Langone Health

Brief Summary

This will be a single-center, prospective observational study. The study will compare post- operative pain scores and narcotic consumption between two groups of patients - one cohort will receive ibuprofen (Motrin) and Percocet (to be used as needed) while the other cohort will receive only Percocet. Both pain management options are considered to be standard of care.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-12-01
• Primary Completion: 2019-02-01
• Study Completion: 2019-02-01
• Study First Submitted: 2019-05-29
• Study First Submitted QC: 2019-07-11
• Study First Posted: 2019-07-12
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-28
• Last Update Posted: 2020-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• ASA class I-II
• Patients scheduled for arthroscopic shoulder instability surgery

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Exclusion Criteria

• Contraindication to ibuprofen 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Percocet	Oxycodone/acetaminophen (Percocet) 5 mg/325	-
Ibuprofen + Percocet	Oxycodone/acetaminophen (Percocet) 5 mg/325	-
Ibuprofen + Percocet	ibuprofen 600 mg	-

Primary Outcome Measures

Name	Time	Method
Change in Visual Analog Scale (VAS) Score	30 Minutes, 1 Hour Post Surgery, 2 Hours Post Surgery, 3 Hours Post Surgery, 4 Hours Post Surgery	Scale consisting of a drawn line from 0 to 100 - the patient will be asked to mark where they believe their pain is (100 being worse pain).
Change in Verbal Rating Scale (VRS)	30 Minutes, 1 Hour Post Surgery, 2 Hours Post Surgery, 3 Hours Post Surgery, 4 Hours Post Surgery	Consisting of 4 points (0 = no pain, 1 = mild, 2 = moderate, and 3 = severe)

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States