Narcotics vs NSAIDs for Post-operative Analgesia in Outpatient Rhinoplasty

Narcotics vs Non-steroidal Ant Inflammatory Drugs Post-operative Analgesia in Outpatient Rhinoplasty

The purpose of this study is to compare the efficacy and safety of oral opiate pain medication vs non-steroidal ant inflammatory drugs (NSAIDs) in the treatment of postoperative rhinoplasty pain. This study will also evaluate potential contributing factors affecting the efficacy of these pain control methods. Patients will be randomized to receive either NSAIDs in the form of 400mg of Ibuprofen or Norco (hydrocodone 5mg- acetaminophen 325mg) to be used for post-operative pain. The study will then compare which is more effective in controlling post operative pain.

Study Overview

• Status: Completed
• Conditions: Opioid Use; Rhinoplasty; Non-steroidal Ant Inflammatory Drugs
• Intervention / Treatment: Drug: NSAID; Drug: Norco

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients 18-70 years old undergoing septorhinoplasty or rhinoplasty for either obstructive or aesthetic reasons. All approaches to rhinoplasty and surgical techniques utilized will be included. This will include patients that undergo additional procedures during the rhinoplasty including osteotomies, turbinate reduction, septoplasty, nasal valve repair and ear cartilage graft.

Exclusion Criteria:

• Patients who undergo a rhinoplasty requiring a rib cartilage graft for the procedure as this is known to cause significant pleuritic chest pain.
• Patients receiving functional endoscopic sinus surgery concurrently with the rhinoplasty will be excluded.
• Patients with known history of gastrointestinal bleeds, peptic ulcer disease or who have other comorbidities that prevent them from taking NSAIDs.
• Patients with a history of radiation, active head and neck malignancy or other pain disorders such as various rheumatologic diseases will be excluded to decrease confounding factors in the control of pain.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NSAIDS; 400mg of Ibuprofen	Drug: NSAID; Ibuprofen 400mg for post-operative pain
Active Comparator: Opiates; Norco (hydrocodone 5mg- acetaminophen 325mg)	Drug: Norco; 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Pain Score	Pain scores are reported via Post-Operative Pain Management Survey. On a scale of 1-10, participants indicate how much pain they were in on their pain regiment. The higher the score, the worse the pain (1 = no pain, 10 = worst pain possible)	Day 0
Average Pain Score	Pain scores are reported via Post-Operative Pain Management Survey. On a scale of 1-10, participants indicate how much pain they were in on their pain regiment. The higher the score, the worse the pain (1 = no pain, 10 = worst pain possible)	Day 1
Average Pain Score	Pain scores are reported via Post-Operative Pain Management Survey. On a scale of 1-10, participants indicate how much pain they were in on their pain regiment. The higher the score, the worse the pain (1 = no pain, 10 = worst pain possible)	Day 7
Average Post-Operative Day (POD) of Medication Cessation	Self-reported via Post-Operative Pain Management Survey	Day 7

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants in NSAIDs Group Who Were Upgraded to Opiates Due to High Levels of Pain	Day 7

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Judy Lee, MD, NYU Langone

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2018
• Primary Completion (Actual): November 2, 2020
• Study Completion (Actual): November 2, 2020

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: March 1, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): November 23, 2021
• Last Update Submitted That Met QC Criteria: October 25, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 17-01839

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Data are available indefinitely at (Link to be included).
• IPD Sharing Access Criteria: Anyone who wishes to access the data.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No