NSAID vs. Narcotics

Multimodal Analgesia Clinical Trial

Official title:

Multimodal Analgesia With NSAID vs. Narcotics Alone for Post-operative Meniscectomy: A Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02915055
• Other study ID #: 16-01645
• Status: Completed
• Phase: N/A
• First received: September 22, 2016
• Last updated: May 4, 2017
• Start date: September 1, 2016
• Est. completion date: March 1, 2017

Study information

• Verified date: May 2017
• Source: New York University School of Medicine
• 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: March 1, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must be at least 18 years of age

• ASA class I-II

• Patients scheduled for meniscectomy

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

• Multimodal Analgesia
• Nonsteroidal Anti-inflammatory Drugs

Intervention

Drug:
• Ibuprofen 600 mg
Ibuprofen 600 mg to be taken every 8 hours (TID) as needed (PRN
• standard oxycodone/acetaminophen

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale (VAS) score	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).	4 Hours
Primary	Pain Verbal Rating Scale	Verbal rating scale, consisting of 4 points (0 = no pain, 1 = mild, 2 = moderate, and 3 = severe).	4 Hours