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

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Pain
• Intervention / Treatment: Other: ibuprofen 600 mg; Other: Oxycodone/acetaminophen (Percocet) 5 mg/325

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients indicated for isolated arthroscopic shoulder instability surgery

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ibuprofen + Percocet	Other: ibuprofen 600 mg; MRN ending in an EVEN # will receive ibuprofen 600 mg to be taken every 8 hours (TID) as needed (PRN) and oxycodone/acetaminophen (Percocet) 5 mg/325 mg for pain that is not adequately controlled by the ibuprofen.; Other: Oxycodone/acetaminophen (Percocet) 5 mg/325; MRN ending in an ODD #: will receive the current standard of care postoperative pain management, which is Percocet 5 mg/325 mg every 6 hours PRN.
Percocet	Other: Oxycodone/acetaminophen (Percocet) 5 mg/325; MRN ending in an ODD #: will receive the current standard of care postoperative pain management, which is Percocet 5 mg/325 mg every 6 hours PRN.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Analog Scale (VAS) Score	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).	30 Minutes, 1 Hour Post Surgery, 2 Hours Post Surgery, 3 Hours Post Surgery, 4 Hours Post Surgery
Change in Verbal Rating Scale (VRS)	Consisting of 4 points (0 = no pain, 1 = mild, 2 = moderate, and 3 = severe)	30 Minutes, 1 Hour Post Surgery, 2 Hours Post Surgery, 3 Hours Post Surgery, 4 Hours Post Surgery

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Kirk Campbell, New York Langone Health

Publications and helpful links

General Publications

• Bloom DA, Baron SL, Luthringer TA, Alaia MJ, Strauss EJ, Jazrawi LM, Campbell KA. Preoperative Opioid Education has No Effect on Opioid Use in Patients Undergoing Arthroscopic Rotator Cuff Repair: A Prospective, Randomized Clinical Trial. J Am Acad Orthop Surg. 2021 Oct 1;29(19):e961-e968. doi: 10.5435/JAAOS-D-20-00594.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2017
• Primary Completion (ACTUAL): February 1, 2019
• Study Completion (ACTUAL): February 1, 2019

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (ACTUAL): July 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 29, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Acetaminophen; Ibuprofen; Oxycodone; Acetaminophen, hydrocodone drug combination
• Other Study ID Numbers: 17-01177

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No