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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04018768

Enrollment

Registered

2019-07-12

Start date

2017-12-01

Completion date

2019-02-01

Last updated

2020-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Pain

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.

Interventions

OTHERibuprofen 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.

OTHEROxycodone/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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026