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Clinical Trials/NCT04018768
NCT04018768
Completed
Not Applicable

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

NYU Langone Health1 site in 1 country80 target enrollmentDecember 1, 2017
ConditionsShoulder Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Shoulder Pain
Sponsor
NYU Langone Health
Enrollment
80
Locations
1
Primary Endpoint
Change in Visual Analog Scale (VAS) Score
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2017
End Date
February 1, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

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

Outcomes

Primary Outcomes

Change in Visual Analog Scale (VAS) Score

Time Frame: 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)

Time Frame: 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)

Study Sites (1)

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