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Pain Control Following Sinus Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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

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

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Oxycodone

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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03783702


Locations
Layout table for location information
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:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Peter Hwang, Principal Investigator, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03783702    
Other Study ID Numbers: 46384
First Posted: December 21, 2018    Key Record Dates
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

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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:
Layout table for 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