Narcotics vs NSAIDs for Post-operative Analgesia in Outpatient Rhinoplasty

Study Overview
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Brief Summary
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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.

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

Conditions
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Rhinoplasty, Non-steroidal Ant Inflammatory Drugs, Opioid Use

Intervention / Treatment
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* Drug: Norco
* Drug: NSAID


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants in NSAIDs Group Who Were Upgraded to Opiates Due to High Levels of Pain |  | Day 7 |