Status:
COMPLETED
Pain Control Following Sinus Surgery
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Mayo Clinic
Vanderbilt University Medical Center
Conditions:
Sinusitis
Opioid Use
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT03783702
Start Date
April 4 2019
End Date
December 30 2020
Last Update
September 1 2021
Active Locations (6)
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1
Stanford Health Care
Stanford, California, United States, 94305
2
NorthShore University Health System
Evanston, Illinois, United States, 60201
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
4
Albert Einstein
The Bronx, New York, United States, 10461