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

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04018768
• Other study ID #: 17-01177
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: February 1, 2019

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

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.
• 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.

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	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
Primary	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