Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty

Study Overview
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Brief Summary
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The purpose of this study is to compare the level of pain control in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs) to those receiving opioids in the postoperative period after endoscopic sinus surgery (ESS) and/or septoplasty.

Official Title
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Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty

Conditions
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Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty

Intervention / Treatment
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* Drug: diclofenac
* Drug: Norco


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: english speaking candidates for endoscopic sinus surgery as determined by medical necessity by the treating rhinologist scheduled for surgery at Texas Sinus Institute Exclusion Criteria: allergy to either NSAIDs or opioids contraindication to NSAIDs (ex. gastritis, chronic kidney disease) surgical plan exceeding basic endoscopic sinus surgery use of anticoagulation the presence of any pain disorder the current usage of any analgesic medication history of opioid addiction pregnancy history of chronic pain or fibromyalgia current daily use of NSAIDs, acetaminophen, opioids or other analgesics (pregabalin, tramadol, etc)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NSAID<br>The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac. | Drug: diclofenac<br>* The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.<br>|
| Active Comparator: opioid<br>The Opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen). | Drug: Norco<br>* The opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).<br>* Other names: Hydrocodone-Acetaminophen combination medication;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS) | The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain. | 24 hours (day 1 after operation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS) | The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain. | 48 hours (day 2 after operation) | 
| Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS) | The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain. | 72 hours (day 3 after operation) | 
| Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS) | The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain. | 120 hours (day 5 after operation) | 
| Number of Participants With Bleeding Complications | Bleeding complications are defined as complications necessitating a trip to the emergency room or requiring intervention for epistaxis. | 5 days after operation | 
| Number of Participants With Constipation |  | 5 days after operation | 
| Number of Participants With Nausea or Vomiting |  | 5 days after operation |