Clinical trial NCT03783702: Pain Control Following Sinus Surgery
Official title: Multi-institutional, Randomized Controlled Trial Assessing Opioid Use and Analgesic Requirements After Endoscopic Sinus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sinusitis
Opioid Use
Opioid Abuse
Narcotic Use
Otolaryngologic Disease
Postoperative Pain
Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
name: Vanderbilt University Medical Center
name: Albert Einstein College of Medicine
name: University of British Columbia
name: Endeavor Health
First posted: 2018-12-21
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain Severity
timeFrame: Average pain score will be collected for preoperative visit (the day before surgery)
measure: Pain Severity
timeFrame: Average pain score was collected for postoperative day 1
measure: Pain Severity
timeFrame: Average pain score will be collected for postoperative day 2
measure: Pain Severity
timeFrame: Average pain score will be collected for postoperative day 3
measure: Pain Severity
timeFrame: Average pain score will be collected for postoperative day 4
measure: Pain Severity
timeFrame: Average pain score will be collected for postoperative day 5
measure: Pain Severity
timeFrame: Average pain score will be collected for postoperative day 6
measure: Pain Severity
timeFrame: Average pain score will be collected for postoperative day 7
measure: Medication Log
timeFrame: Postoperative day 1 to 7
Secondary outcomes:
measure: Brief Pain Inventory (BPI) Score
timeFrame: BPI score will be collected at the preoperative visit
measure: Brief Pain Inventory (BPI) Score
timeFrame: Average BPI score will be collected for postoperative day 1
measure: Brief Pain Inventory (BPI) Score
timeFrame: Average BPI score will be collected for postoperative day 2
measure: Brief Pain Inventory (BPI) Score
timeFrame: Average BPI score will be collected for postoperative day 3
measure: Brief Pain Inventory (BPI) Score
timeFrame: Average BPI score will be collected for postoperative day 4
measure: Brief Pain Inventory (BPI) Score
timeFrame: Average BPI score will be collected for postoperative day 5
measure: Brief Pain Inventory (BPI) Score
timeFrame: Average BPI score will be collected for postoperative day 6
measure: Brief Pain Inventory (BPI) Score
timeFrame: Average BPI score will be collected for postoperative day 7
measure: Severity of Epistaxis
timeFrame: Epistaxis severity will be collected at the preoperative visit
measure: Severity of Epistaxis
timeFrame: Epistaxis severity will be collected for postoperative day 1
measure: Severity of Epistaxis
timeFrame: Epistaxis severity will be collected for postoperative day 2
measure: Severity of Epistaxis
timeFrame: Epistaxis severity will be collected for postoperative day 3
measure: Severity of Epistaxis
timeFrame: Epistaxis severity will be collected for postoperative day 4
measure: Severity of Epistaxis
timeFrame: Epistaxis severity will be collected for postoperative day 5
measure: Severity of Epistaxis
timeFrame: Epistaxis severity will be collected for postoperative day 6
measure: Severity of Epistaxis
timeFrame: Epistaxis severity will be collected for postoperative day 7
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Health Care
state: California
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Bronx
country: United States
facility: Albert Einstein
state: New York
city: Nashville
country: United States
facility: Vanderbilt
state: Tennessee
city: Vancouver
country: Canada
facility: University of British Columbia
Study officials:
References:
citation: Bhattacharyya N. Ambulatory sinus and nasal surgery in the United States: demographics and perioperative outcomes. Laryngoscope. 2010 Mar;120(3):635-8. doi: 10.1002/lary.20777.
citation: Schwartz MA, Naples JG, Kuo CL, Falcone TE. Opioid Prescribing Patterns among Otolaryngologists. Otolaryngol Head Neck Surg. 2018 May;158(5):854-859. doi: 10.1177/0194599818757959. Epub 2018 Feb 20.
citation: Svider PF, Arianpour K, Guo E, Folbe E, Zuliani G, Lin H, Eloy JA, Folbe AJ. Opioid prescribing patterns among otolaryngologists: Crucial insights among the medicare population. Laryngoscope. 2018 Jul;128(7):1576-1581. doi: 10.1002/lary.27101. Epub 2018 Feb 15.
citation: Mohan S, Bhattacharyya N. Opioids and the Otolaryngologist: An Ambulatory Assessment. Otolaryngol Head Neck Surg. 2018 Jul;159(1):29-34. doi: 10.1177/0194599818765125. Epub 2018 Mar 20.
citation: Ayoub NF, Choby G, Turner JH, Abuzeid WM, Raviv JR, Thamboo A, Ma Y, Chandra RK, Chowdhury NI, Stokken JK, O'Brien EK, Shah S, Akbar N, Roozdar P, Nayak JV, Patel ZM, Hwang PH. Assessment of Opioid Use and Analgesic Requirements After Endoscopic Sinus Surgery: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 Sep 1;147(9):811-819. doi: 10.1001/jamaoto.2021.1839.