Pain Control Following Sinus Surgery

Pain Clinical Trial

Official title:

Multi-institutional, Randomized Controlled Trial Assessing Opioid Use and Analgesic Requirements After Endoscopic Sinus Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03783702
• Other study ID #: 46384
• Status: Completed
• Phase: Phase 4
• Start date: April 4, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: August 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: December 30, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Narcotic Use
• Opioid Abuse
• Opioid Use
• Opioid-Related Disorders
• Otolaryngologic Disease
• Otorhinolaryngologic Diseases
• Pain
• Postoperative Pain
• Sinusitis

Intervention

Drug:
• OxyCODONE 5 Mg (milligram) Oral Tablet
Oxycodone will be the second-line treatment in the control group and the third-line treatment in the experimental group.
• Ibuprofen 600 Mg (milligram) Oral Tablet
Patients in the experimental group will receive ibuprofen 600mg as the second-line analgesic.
• Acetaminophen 650 MG (milligram) Oral Tablet
All patients will receive acetaminophen as the first-line analgesic.

Locations

Country	Name	City	State
Canada	University of British Columbia	Vancouver
United States	Albert Einstein	Bronx	New York
United States	NorthShore University Health System	Evanston	Illinois
United States	Vanderbilt	Nashville	Tennessee
United States	Mayo Clinic	Rochester	Minnesota
United States	Stanford Health Care	Stanford	California

Sponsors (6)

Lead Sponsor	Collaborator
Stanford University	Albert Einstein College of Medicine, Mayo Clinic, NorthShore University HealthSystem, University of British Columbia, Vanderbilt University Medical Center

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Severity	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.	Average pain score will be collected for preoperative visit (the day before surgery)
Primary	Pain Severity	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.	Average pain score was collected for postoperative day 1
Primary	Pain Severity	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.	Average pain score will be collected for postoperative day 2
Primary	Pain Severity	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.	Average pain score will be collected for postoperative day 3
Primary	Pain Severity	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.	Average pain score will be collected for postoperative day 4
Primary	Pain Severity	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.	Average pain score will be collected for postoperative day 5
Primary	Pain Severity	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.	Average pain score will be collected for postoperative day 6
Primary	Pain Severity	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.	Average pain score will be collected for postoperative day 7
Primary	Medication Log	Patients kept a daily medication log and reported the number of doses consumed per day (650mg acetaminophen, 600mg ibuprofen, 5mg oxycodone). The mean number of medication doses per day was calculated for each treatment group.	Postoperative day 1 to 7
Secondary	Brief Pain Inventory (BPI) Score	The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).; Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.	BPI score will be collected at the preoperative visit
Secondary	Brief Pain Inventory (BPI) Score	The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).; Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.	Average BPI score will be collected for postoperative day 1
Secondary	Brief Pain Inventory (BPI) Score	The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).; Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.	Average BPI score will be collected for postoperative day 2
Secondary	Brief Pain Inventory (BPI) Score	The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).; Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.	Average BPI score will be collected for postoperative day 3
Secondary	Brief Pain Inventory (BPI) Score	The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).; Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.	Average BPI score will be collected for postoperative day 4
Secondary	Brief Pain Inventory (BPI) Score	The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).; Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.	Average BPI score will be collected for postoperative day 5
Secondary	Brief Pain Inventory (BPI) Score	The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).; Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.	Average BPI score will be collected for postoperative day 6
Secondary	Brief Pain Inventory (BPI) Score	The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).; Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.	Average BPI score will be collected for postoperative day 7
Secondary	Severity of Epistaxis	A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.	Epistaxis severity will be collected at the preoperative visit
Secondary	Severity of Epistaxis	A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.	Epistaxis severity will be collected for postoperative day 1
Secondary	Severity of Epistaxis	A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.	Epistaxis severity will be collected for postoperative day 2
Secondary	Severity of Epistaxis	A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.	Epistaxis severity will be collected for postoperative day 3
Secondary	Severity of Epistaxis	A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.	Epistaxis severity will be collected for postoperative day 4
Secondary	Severity of Epistaxis	A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.	Epistaxis severity will be collected for postoperative day 5
Secondary	Severity of Epistaxis	A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.	Epistaxis severity will be collected for postoperative day 6
Secondary	Severity of Epistaxis	A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.	Epistaxis severity will be collected for postoperative day 7