Pain Control Following Sinus Surgery



Status:Not yet recruiting
Conditions:Chronic Pain, Post-Surgical Pain, Sinusitis, Psychiatric
Therapuetic Areas:Musculoskeletal, Otolaryngology, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:12/23/2018
Start Date:December 20, 2018
End Date:December 31, 2019
Contact:Noel F Ayoub, MD MBA
Email:nfa@stanford.edu
Phone:(650) 725-6500

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Efficacy of Non-Opioid Analgesics in the Management of Pain Following Endoscopic Sinus Surgery: A Multi-Institutional Randomized Controlled Trial

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.


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.
We found this trial at
6
sites
Rochester, Minnesota 55905
Principal Investigator: Garret Choby, MD
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from
Rochester, MN
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Bronx, New York 10467
Principal Investigator: Waleed Abuzeid, MD
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from
Bronx, NY
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Evanston, Illinois 60201
Principal Investigator: Joseph Raviv, MD
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from
Evanston, IL
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Nashville, Tennessee 37212
Principal Investigator: Justin Turner, MD
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from
Nashville, TN
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Stanford, California 94304
Principal Investigator: Peter H Hwang, MD
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from
Stanford, CA
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Vancouver,
Principal Investigator: Andrew Thamboo, MD
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from
Vancouver,
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