Pain Control Following Sinus Surgery

Study Overview
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Brief Summary
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Given the ongoing national opioid epidemic, an increased interest has developed in optimizing opioid prescribing practices of physicians, including otolaryngologists. Endoscopic sinus surgery (ESS) is one of the most commonly performed surgeries by otolaryngologists with over 250,000 ESS's performed annually in the U.S. Multiple studies have shown that, compared to the amount patients actually consume, otolaryngologists prescribe a high quantity of opioids to patients recovering from ESS). It has been shown that these excess opioid medications contribute to prolonged use or abuse by the patient, family members, or friends. The purpose of this study is to better understand the pain management requirements of patients who undergo ESS for recurrent acute rhinosinusitis (RARS) or chronic rhinosinusitis (CRS). This prospective, randomized, multi-institutional controlled trial will aim to determine the degree to which pain following ESS can be adequately controlled by non-opioid medications. It will also determine whether post-ESS narcotic use can be avoided entirely, or at least significantly limited. Patients will be randomized into two groups, each of which will receive a stepwise analgesic regimen consisting of acetaminophen and oxycodone or acetaminophen and ibuprofen. Pain will be assessed daily using visual analog scales (VAS) and the Brief Pain Inventory (BPI). The results of this study will help to develop a standardized approach to pain management in the post-ESS setting and help to elucidate the role of non-opioid pain medications. The ultimate goal would be to positively affect opioid prescribing patterns among surgeons who perform ESS in order to significantly reduce the quantity of opioids prescribed to patients while continuing to adequately manage patients' pain.

Official Title
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Multi-institutional, Randomized Controlled Trial Assessing Opioid Use and Analgesic Requirements After Endoscopic Sinus Surgery

Conditions
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Sinusitis, Opioid Use, Opioid Abuse, Narcotic Use, Otolaryngologic Disease, Postoperative Pain, Pain

Intervention / Treatment
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* Drug: OxyCODONE 5 Mg (milligram) Oral Tablet
* Drug: Ibuprofen 600 Mg (milligram) Oral Tablet
* Drug: Acetaminophen 650 MG (milligram) Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older English-speaking Scheduled to undergo endoscopic sinus surgery for sinusitis (CRSwNP, CRSsNP, or RARS) Can commit to follow up for at least one postoperative visit Exclusion Criteria: Patients undergoing a septorhinoplasty (septoplasty permissible if patient will also undergo sinus surgery) Doyle splints to be used Alcohol or opioid use disorder History of chronic pain disorders Regular use of acetaminophen/NSAIDS (>4x per week) Patients who use narcotics or neuromodulating drugs (e.g. gabapentin, nortriptyline)more than 2x per week on average. Gastrointestinal ulcers or bleeding Chronic kidney disease/known decreased renal function (estimated glomerular filtration rate <60) Liver cirrhosis or other hepatic impairment Prior adverse reaction to opioids or NSAIDS Other contraindications to any drug classes in either group.

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
Interventional Model Description: Patients will be randomized into one of two groups: one will receive acetaminophen and oxycodone while the other will receive acetaminophen, ibuprofen, and oxycodone.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Patients in the experimental group will be asked to start with acetaminophen (650mg tablet by mouth every 6 hours) when they are in pain. If they still require additional analgesics, the second-line medication is ibuprofen (600mg tablet by mouth every 6 hours). Oxycodone (5mg tablet by mouth every 4 hours) will be the third-line medication to be used if acetaminophen and ibuprofen do not sufficiently control the pain. | Drug: OxyCODONE 5 Mg (milligram) Oral Tablet<br>* Oxycodone will be the second-line treatment in the control group and the third-line treatment in the experimental group.<br>Drug: Ibuprofen 600 Mg (milligram) Oral Tablet<br>* Patients in the experimental group will receive ibuprofen 600mg as the second-line analgesic.<br>Drug: Acetaminophen 650 MG (milligram) Oral Tablet<br>* All patients will receive acetaminophen as the first-line analgesic.<br>|
| Active Comparator: Control group<br>Patients in the control group will be asked to start with acetaminophen (650mg tablet by mouth every 6 hours) when they are in pain. If they still require additional analgesics, the second-line medication is oxycodone (5mg tablet by mouth every 4 hours). | Drug: OxyCODONE 5 Mg (milligram) Oral Tablet<br>* Oxycodone will be the second-line treatment in the control group and the third-line treatment in the experimental group.<br>Drug: Acetaminophen 650 MG (milligram) Oral Tablet<br>* All patients will receive acetaminophen as the first-line analgesic.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Severity | A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no pain with a score of 0 to worst imaginable pain, corresponding to a score of 100. | Average pain score will be collected for preoperative visit (the day before surgery) | 
| Pain Severity | A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no pain with a score of 0 to worst imaginable pain, corresponding to a score of 100. | Average pain score was collected for postoperative day 1 | 
| Pain Severity | A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no pain with a score of 0 to worst imaginable pain, corresponding to a score of 100. | Average pain score will be collected for postoperative day 2 | 
| Pain Severity | A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no pain with a score of 0 to worst imaginable pain, corresponding to a score of 100. | Average pain score will be collected for postoperative day 3 | 
| Pain Severity | A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no pain with a score of 0 to worst imaginable pain, corresponding to a score of 100. | Average pain score will be collected for postoperative day 4 | 
| Pain Severity | A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no pain with a score of 0 to worst imaginable pain, corresponding to a score of 100. | Average pain score will be collected for postoperative day 5 | 
| Pain Severity | A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no pain with a score of 0 to worst imaginable pain, corresponding to a score of 100. | Average pain score will be collected for postoperative day 6 | 
| Pain Severity | A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no pain with a score of 0 to worst imaginable pain, corresponding to a score of 100. | Average pain score will be collected for postoperative day 7 | 
| Medication Log | Patients kept a daily medication log and reported the number of doses consumed per day (650mg acetaminophen, 600mg ibuprofen, 5mg oxycodone). The mean number of medication doses per day was calculated for each treatment group. | Postoperative day 1 to 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory (BPI) Score | The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its least, worst, average, and now. The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318. | BPI score will be collected at the preoperative visit | 
| Brief Pain Inventory (BPI) Score | The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its least, worst, average, and now. The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318. | Average BPI score will be collected for postoperative day 1 | 
| Brief Pain Inventory (BPI) Score | The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its least, worst, average, and now. The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318. | Average BPI score will be collected for postoperative day 2 | 
| Brief Pain Inventory (BPI) Score | The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its least, worst, average, and now. The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318. | Average BPI score will be collected for postoperative day 3 | 
| Brief Pain Inventory (BPI) Score | The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its least, worst, average, and now. The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318. | Average BPI score will be collected for postoperative day 4 | 
| Brief Pain Inventory (BPI) Score | The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its least, worst, average, and now. The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318. | Average BPI score will be collected for postoperative day 5 | 
| Brief Pain Inventory (BPI) Score | The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its least, worst, average, and now. The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318. | Average BPI score will be collected for postoperative day 6 | 
| Brief Pain Inventory (BPI) Score | The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its least, worst, average, and now. The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318. | Average BPI score will be collected for postoperative day 7 | 
| Severity of Epistaxis | A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100. | Epistaxis severity will be collected at the preoperative visit | 
| Severity of Epistaxis | A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100. | Epistaxis severity will be collected for postoperative day 1 | 
| Severity of Epistaxis | A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100. | Epistaxis severity will be collected for postoperative day 2 | 
| Severity of Epistaxis | A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100. | Epistaxis severity will be collected for postoperative day 3 | 
| Severity of Epistaxis | A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100. | Epistaxis severity will be collected for postoperative day 4 | 
| Severity of Epistaxis | A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100. | Epistaxis severity will be collected for postoperative day 5 | 
| Severity of Epistaxis | A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100. | Epistaxis severity will be collected for postoperative day 6 | 
| Severity of Epistaxis | A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100. | Epistaxis severity will be collected for postoperative day 7 |