Postoperative Pain Management in Rhinoplasty

Study Overview
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Brief Summary
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The primary purpose of the study is to determine adequacy of postoperative pain control after nasal surgery in patients prescribed Acetaminophen (325mg) + Hydrocodone (5mg) compared to Acetaminophen(325mg) + Ibuprofen (200mg)for a period of 5 days after nasal surgery. To assess the degree of pain, the participants will score the intensity of their pain on a visual analog scale(VAS)of 0-100points (0- no pain and 100- most severe pain), preoperatively and postoperatively (to be documented before each dose) for the duration of the prescribed medications . Additionally, the study will also seek to track: The total number of pills each patients consume from the prescribed 5 day regimen. Any associated side effects. Additional pain medications prescribed in case of inadequate pain control, postoperatively.

Detailed Description
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From this study, the investigators hope to learn the following: Is adequate postoperative pain management after nasal surgery achieved with opioid or non-opioid drugs? If opioid drugs are required for adequate pain control postoperatively, is it possible to reduce the number of days the drugs are prescribed for? What are the common side effect profiles of the included drugs? In light of the current opioid epidemic in the country, it is important the the physicians explore the utility of drugs other than opioids for adequate postoperative pain management. Also, reducing the dosage and/or number of prescribed opioid drugs lessens the propensity for misuse of physician prescribed opioid medications.

Official Title
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Postoperative Pain Management in Rhinoplasty: A Randomized Controlled Trial

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Norco 5Mg-325Mg Tablet
* Drug: Tylenol 325Mg Caplet
* Drug: Ibuprofen 200 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum age of 18 years Able to speak and understand english. Undergoing rhinoplasty for cosmetic purposes Undergoing rhinoplasty for treatment of nasal obstruction Exclusion Criteria: Less than 18 years of age Cannot speak and understand english Patients who have undergone nasal surgery in the past Patients not undergoing nasal surgery Women will be excluded if they are either pregnant or lactating as this population does not undergo nasal surgery at our center. Patients with any known allergies to the class of pain medications used in the study. Please note: Any person interested in this clinical trial should contact the Facial Plastic and Reconstructive Surgery clinic at (650) 736 - FACE (3223) to schedule a consultation with Dr. Sam P. Most to assess their eligibility for the trial. Please note, enrolling in the clinical trial will not entitle the participant to a waiver of charges associated with undergoing nasal surgery.

Ages Eligible for Study
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Minimum Age: 18 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DRUG ARM A<br>Norco 5Mg-325Mg Tablet, administered orally every 4 hours for 5 days total | Drug: Norco 5Mg-325Mg Tablet<br>* Opioid Analgesics<br>* Other names: Hycet;|
| Active Comparator: DRUG ARM B<br>Tylenol 325Mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total. | Drug: Tylenol 325Mg Caplet<br>* Non opioid analgesics<br>* Other names: Acetaminophen;Drug: Ibuprofen 200 mg<br>* Non opioid analgesics<br>* Other names: Motrin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity Visual Analog Scale (VAS)- 0-100 (0- no pain and 100- most severe pain) | Self reported pain intensity at every prescribed dose for a period of 5 days. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects of pain medications | Self reported side effects of prescribed medications | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pain, Rhinoplasty