NSAID vs. Narcotics

Completed

• Conditions: Multimodal Analgesia; Nonsteroidal Anti-inflammatory Drugs
• Interventions: Drug: Ibuprofen 600 mg; Drug: standard oxycodone/acetaminophen

• Registration Number: NCT02915055
• 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.

The primary objective of the study is to compare patients' reported pain and narcotic use following meniscectomy, and determine if NSAIDs can provide adequate pain relief.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2016-09-22
• Study First Submitted QC: 2016-09-22
• Study First Posted: 2016-09-26
• Primary Completion: 2017-03-01
• Study Completion: 2017-03-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-04
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• Must be at least 18 years of age
• ASA class I-II
• Patients scheduled for meniscectomy

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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
Patients with pain following knee arthroscopic meniscectomy	standard oxycodone/acetaminophen	-
Patients with pain following knee arthroscopic meniscectomy	Ibuprofen 600 mg	-

Primary Outcome Measures

Name	Time	Method
Visual analogue scale (VAS) score	4 Hours	Scale consisting of a drawn line from 0 to 100 - you will be asked to mark where you believe your pain is (100 being worse pain).
Pain Verbal Rating Scale	4 Hours	Verbal rating scale, 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