Pain Control Following Sinus Surgery
Completed · Phase 4
Conditions studied: Sinusitis, Opioid Use, Opioid Abuse, Narcotic Use, Otolaryngologic Disease, Postoperative Pain, Pain
In brief
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.
Key facts
- Study ID
- NCT03783702
- Run by
- Stanford University
- People needed
- 118
- Starts
- 2019-04-04
- Expected to finish
- 2020-12-30
- Last updated by the study team
- 2021-09-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Stanford Health Care — Stanford, California, United States
- NorthShore University Health System — Evanston, Illinois, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Albert Einstein — The Bronx, New York, United States
- Vanderbilt — Nashville, Tennessee, United States
- University of British Columbia — Vancouver, Canada
Full record on ClinicalTrials.gov
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