Pain Control Following Sinus Surgery
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ClinicalTrials.gov Identifier: NCT03783702 |
Recruitment Status :
Recruiting
First Posted : December 21, 2018
Last Update Posted : September 20, 2019
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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.
Condition or disease | Intervention/treatment | Phase |
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Sinusitis Opioid Use Opioid Abuse Narcotic Use Otolaryngologic Disease Postoperative Pain Pain | Drug: OxyCODONE 5 Mg Oral Tablet Drug: Ibuprofen 600 Mg Oral Tablet Drug: Acetaminophen 650 MG Oral Tablet | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 180 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention 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) |
Primary Purpose: | Treatment |
Official Title: | Efficacy of Non-Opioid Analgesics in the Management of Pain Following Endoscopic Sinus Surgery: A Multi-Institutional Randomized Controlled Trial |
Actual Study Start Date : | April 4, 2019 |
Estimated Primary Completion Date : | October 1, 2019 |
Estimated Study Completion Date : | December 31, 2019 |

Arm | Intervention/treatment |
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Experimental: Experimental group
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.
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Drug: OxyCODONE 5 Mg Oral Tablet
Oxycodone will be the second-line treatment in the control group and the third-line treatment in the experimental group. Drug: Ibuprofen 600 Mg Oral Tablet Patients in the experimental group will receive ibuprofen 600mg as the second-line analgesic. Drug: Acetaminophen 650 MG Oral Tablet All patients will receive acetaminophen as the first-line analgesic. |
Active Comparator: Control group
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).
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Drug: OxyCODONE 5 Mg Oral Tablet
Oxycodone will be the second-line treatment in the control group and the third-line treatment in the experimental group. Drug: Acetaminophen 650 MG Oral Tablet All patients will receive acetaminophen as the first-line analgesic. |
- Pain severity [ Time Frame: Average pain score will be collected for preoperative visit (the day before surgery) ]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.
- Pain severity [ Time Frame: Average pain score will be collected for postoperative day 1 ]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.
- Pain severity [ Time Frame: Average pain score will be collected for postoperative day 2 ]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.
- Pain severity [ Time Frame: Average pain score will be collected for postoperative day 3 ]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.
- Pain severity [ Time Frame: Average pain score will be collected for postoperative day 4 ]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.
- Pain severity [ Time Frame: Average pain score will be collected for postoperative day 5 ]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.
- Pain severity [ Time Frame: Average pain score will be collected for postoperative day 6 ]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.
- Pain severity [ Time Frame: Average pain score will be collected for postoperative day 7 ]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.
- Medication log [ Time Frame: Preoperative visit (the day before surgery) to postoperative day 7 ]Patients will keep a detailed log of any analgesics they take. The number of each time of medication will be counted and added to determine total medication consumption. This will be reported as an outcome measure.
- Brief Pain Inventory (BPI) Score [ Time Frame: BPI score will be collected at the preoperative visit ]The BPI is a 15-item, validated patient-reported outcome measure used to assess pain severity.
- Brief Pain Inventory (BPI) Score [ Time Frame: Average BPI score will be collected for postoperative day 1 ]The BPI is a 15-item, validated patient-reported outcome measure used to assess pain severity.
- Brief Pain Inventory (BPI) Score [ Time Frame: Average BPI score will be collected for postoperative day 2 ]The BPI is a 15-item, validated patient-reported outcome measure used to assess pain severity.
- Brief Pain Inventory (BPI) Score [ Time Frame: Average BPI score will be collected for postoperative day 3 ]The BPI is a 15-item, validated patient-reported outcome measure used to assess pain severity.
- Brief Pain Inventory (BPI) Score [ Time Frame: Average BPI score will be collected for postoperative day 4 ]The BPI is a 15-item, validated patient-reported outcome measure used to assess pain severity.
- Brief Pain Inventory (BPI) Score [ Time Frame: Average BPI score will be collected for postoperative day 5 ]The BPI is a 15-item, validated patient-reported outcome measure used to assess pain severity.
- Brief Pain Inventory (BPI) Score [ Time Frame: Average BPI score will be collected for postoperative day 6 ]The BPI is a 15-item, validated patient-reported outcome measure used to assess pain severity.
- Brief Pain Inventory (BPI) Score [ Time Frame: Average BPI score will be collected for postoperative day 7 ]The BPI is a 15-item, validated patient-reported outcome measure used to assess pain severity.
- Severity of epistaxis [ Time Frame: Epistaxis severity will be collected at the preoperative visit ]The severity of epistaxis will be recorded using a VAS score ranging from "No bleeding" to "continuous bleeding."
- Severity of epistaxis [ Time Frame: Epistaxis severity will be collected for postoperative day 1 ]The severity of epistaxis will be recorded using a VAS score ranging from "No bleeding" to "continuous bleeding."
- Severity of epistaxis [ Time Frame: Epistaxis severity will be collected for postoperative day 2 ]The severity of epistaxis will be recorded using a VAS score ranging from "No bleeding" to "continuous bleeding."
- Severity of epistaxis [ Time Frame: Epistaxis severity will be collected for postoperative day 3 ]The severity of epistaxis will be recorded using a VAS score ranging from "No bleeding" to "continuous bleeding."
- Severity of epistaxis [ Time Frame: Epistaxis severity will be collected for postoperative day 4 ]The severity of epistaxis will be recorded using a VAS score ranging from "No bleeding" to "continuous bleeding."
- Severity of epistaxis [ Time Frame: Epistaxis severity will be collected for postoperative day 5 ]The severity of epistaxis will be recorded using a VAS score ranging from "No bleeding" to "continuous bleeding."
- Severity of epistaxis [ Time Frame: Epistaxis severity will be collected for postoperative day 6 ]The severity of epistaxis will be recorded using a VAS score ranging from "No bleeding" to "continuous bleeding."
- Severity of epistaxis [ Time Frame: Epistaxis severity will be collected for postoperative day 7 ]The severity of epistaxis will be recorded using a VAS score ranging from "No bleeding" to "continuous bleeding."

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03783702
Contact: Noel F Ayoub, MD MBA | (650) 725-6500 | nfa@stanford.edu | |
Contact: Peter Hwang, MD | hwangph@stanford.edu |
United States, California | |
Stanford Health Care | Recruiting |
Stanford, California, United States, 94305 | |
Contact: Noel F Ayoub, MD MBA nfa@stanford.edu | |
Principal Investigator: Peter H Hwang, MD | |
United States, Illinois | |
NorthShore University Health System | Not yet recruiting |
Evanston, Illinois, United States, 60201 | |
Contact: Gnathan Carpenter, RN BSN | |
Principal Investigator: Joseph Raviv, MD | |
United States, Minnesota | |
Mayo Clinic | Not yet recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Melanie Thompson, CCRP | |
Principal Investigator: Garret Choby, MD | |
United States, New York | |
Albert Einstein | Not yet recruiting |
Bronx, New York, United States, 10461 | |
Contact: Sharan Shah | |
Principal Investigator: Waleed Abuzeid, MD | |
United States, Tennessee | |
Vanderbilt | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Contact: Cindy Dorminy | |
Principal Investigator: Justin Turner, MD | |
Canada | |
University of British Columbia | Not yet recruiting |
Vancouver, Canada | |
Contact: Sara Derikvand | |
Principal Investigator: Andrew Thamboo, MD |
Responsible Party: | Peter Hwang, Principal Investigator, Professor, Stanford University |
ClinicalTrials.gov Identifier: | NCT03783702 |
Other Study ID Numbers: |
46384 |
First Posted: | December 21, 2018 Key Record Dates |
Last Update Posted: | September 20, 2019 |
Last Verified: | September 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Sinusitis Otorhinolaryngologic Diseases Opioid-Related Disorders Paranasal Sinus Diseases Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Acetaminophen Ibuprofen Oxycodone Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antipyretics Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Analgesics, Opioid Narcotics Central Nervous System Depressants |