Pain Control Following Sinus Surgery

• ClinicalTrials.gov Identifier: NCT03783702
• Recruitment Status: Completed
• First Posted: December 21, 2018
• Results First Posted: September 1, 2021
• Last Update Posted: September 1, 2021
• Sponsor: Stanford University
• Collaborators: Mayo Clinic; Vanderbilt University Medical Center; Albert Einstein College of Medicine; University of British Columbia; NorthShore University HealthSystem
• Information provided by (Responsible Party): Peter Hwang, Stanford University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sinusitis; Opioid Use; Opioid Abuse; Narcotic Use; Otolaryngologic Disease; Postoperative Pain; Pain	Drug: OxyCODONE 5 Mg (milligram) Oral Tablet; Drug: Ibuprofen 600 Mg (milligram) Oral Tablet; Drug: Acetaminophen 650 MG (milligram) Oral Tablet	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 118 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multi-institutional, Randomized Controlled Trial Assessing Opioid Use and Analgesic Requirements After Endoscopic Sinus Surgery
• Actual Study Start Date: April 4, 2019
• Actual Primary Completion Date: July 1, 2020
• Actual Study Completion Date: December 30, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Experimental group; Patients in the experimental group will be asked to start with acetaminophen (650mg tablet by mouth every 6 hours) when they are in pain. If they still require additional analgesics, the second-line medication is ibuprofen (600mg tablet by mouth every 6 hours). Oxycodone (5mg tablet by mouth every 4 hours) will be the third-line medication to be used if acetaminophen and ibuprofen do not sufficiently control the pain.	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.; Drug: Ibuprofen 600 Mg (milligram) Oral Tablet; Patients in the experimental group will receive ibuprofen 600mg as the second-line analgesic.; Drug: Acetaminophen 650 MG (milligram) Oral Tablet; All patients will receive acetaminophen as the first-line analgesic.
Active Comparator: Control group; Patients in the control group will be asked to start with acetaminophen (650mg tablet by mouth every 6 hours) when they are in pain. If they still require additional analgesics, the second-line medication is oxycodone (5mg tablet by mouth every 4 hours).	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.; Drug: Acetaminophen 650 MG (milligram) Oral Tablet; All patients will receive acetaminophen as the first-line analgesic.

Outcome Measures

Primary Outcome Measures :

1. Pain Severity [ Time Frame: Average pain score will be collected for preoperative visit (the day before surgery) ]
   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.
2. Pain Severity [ Time Frame: Average pain score was collected for postoperative day 1 ]
   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.
3. Pain Severity [ Time Frame: Average pain score will be collected for postoperative day 2 ]
   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.
4. Pain Severity [ Time Frame: Average pain score will be collected for postoperative day 3 ]
   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.
5. Pain Severity [ Time Frame: Average pain score will be collected for postoperative day 4 ]
   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.
6. Pain Severity [ Time Frame: Average pain score will be collected for postoperative day 5 ]
   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.
7. Pain Severity [ Time Frame: Average pain score will be collected for postoperative day 6 ]
   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.
8. Pain Severity [ Time Frame: Average pain score will be collected for postoperative day 7 ]
   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.
9. Medication Log [ Time Frame: Postoperative day 1 to 7 ]
   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.

Secondary Outcome Measures :

1. Brief Pain Inventory (BPI) Score [ Time Frame: BPI score will be collected at the preoperative visit ]

   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.

2. Brief Pain Inventory (BPI) Score [ Time Frame: Average BPI score will be collected for postoperative day 1 ]

   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.

3. Brief Pain Inventory (BPI) Score [ Time Frame: Average BPI score will be collected for postoperative day 2 ]

   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.

4. Brief Pain Inventory (BPI) Score [ Time Frame: Average BPI score will be collected for postoperative day 3 ]

   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.

5. Brief Pain Inventory (BPI) Score [ Time Frame: Average BPI score will be collected for postoperative day 4 ]

   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.

6. Brief Pain Inventory (BPI) Score [ Time Frame: Average BPI score will be collected for postoperative day 5 ]

   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.

7. Brief Pain Inventory (BPI) Score [ Time Frame: Average BPI score will be collected for postoperative day 6 ]

   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.

8. Brief Pain Inventory (BPI) Score [ Time Frame: Average BPI score will be collected for postoperative day 7 ]

   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.

9. Severity of Epistaxis [ Time Frame: Epistaxis severity will be collected at the preoperative visit ]
   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.
10. Severity of Epistaxis [ Time Frame: Epistaxis severity will be collected for postoperative day 1 ]
    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.
11. Severity of Epistaxis [ Time Frame: Epistaxis severity will be collected for postoperative day 2 ]
    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.
12. Severity of Epistaxis [ Time Frame: Epistaxis severity will be collected for postoperative day 3 ]
    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.
13. Severity of Epistaxis [ Time Frame: Epistaxis severity will be collected for postoperative day 4 ]
    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.
14. Severity of Epistaxis [ Time Frame: Epistaxis severity will be collected for postoperative day 5 ]
    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.
15. Severity of Epistaxis [ Time Frame: Epistaxis severity will be collected for postoperative day 6 ]
    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.
16. Severity of Epistaxis [ Time Frame: Epistaxis severity will be collected for postoperative day 7 ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

Stanford Health Care

Stanford, California, United States, 94305

United States, Illinois

NorthShore University Health System

Evanston, Illinois, United States, 60201

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

United States, New York

Albert Einstein

Bronx, New York, United States, 10461

United States, Tennessee

Vanderbilt

Nashville, Tennessee, United States, 37232

Canada

University of British Columbia

Vancouver, Canada

Sponsors and Collaborators

Stanford University

Mayo Clinic

Vanderbilt University Medical Center

Albert Einstein College of Medicine

University of British Columbia

NorthShore University HealthSystem

  Study Documents (Full-Text)

Documents provided by Peter Hwang, Stanford University:

Study Protocol and Statistical Analysis Plan  [PDF] August 7, 2018

More Information

Publications:

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Peter Hwang, Principal Investigator, Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT03783702
• Other Study ID Numbers: 46384
• First Posted: December 21, 2018
• Results First Posted: September 1, 2021
• Last Update Posted: September 1, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Sinusitis; Otorhinolaryngologic Diseases; Opioid-Related Disorders; Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Acetaminophen; Ibuprofen; Oxycodone; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Antipyretics; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Analgesics, Opioid; Narcotics; Central Nervous System Depressants