Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03783702
Recruitment Status : Recruiting
First Posted : December 21, 2018
Last Update Posted : September 20, 2019
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 Oral Tablet Drug: Ibuprofen 600 Mg Oral Tablet Drug: Acetaminophen 650 MG Oral Tablet Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 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: Efficacy of Non-Opioid Analgesics in the Management of Pain Following Endoscopic Sinus Surgery: A Multi-Institutional Randomized Controlled Trial
Actual Study Start Date : April 4, 2019
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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 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 Oral Tablet
Patients in the experimental group will receive ibuprofen 600mg as the second-line analgesic.

Drug: Acetaminophen 650 MG 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 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 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 will be 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: Preoperative visit (the day before surgery) to postoperative day 7 ]
    Patients will keep a detailed log of any analgesics they take. The number of each time of medication will be counted and added to determine total medication consumption. This will be reported as an outcome measure.


Secondary Outcome Measures :
  1. Brief Pain Inventory (BPI) Score [ Time Frame: BPI score will be collected at the preoperative visit ]
    The BPI is a 15-item, validated patient-reported outcome measure used to assess pain severity.

  2. Brief Pain Inventory (BPI) Score [ Time Frame: Average BPI score will be collected for postoperative day 1 ]
    The BPI is a 15-item, validated patient-reported outcome measure used to assess pain severity.

  3. Brief Pain Inventory (BPI) Score [ Time Frame: Average BPI score will be collected for postoperative day 2 ]
    The BPI is a 15-item, validated patient-reported outcome measure used to assess pain severity.

  4. Brief Pain Inventory (BPI) Score [ Time Frame: Average BPI score will be collected for postoperative day 3 ]
    The BPI is a 15-item, validated patient-reported outcome measure used to assess pain severity.

  5. Brief Pain Inventory (BPI) Score [ Time Frame: Average BPI score will be collected for postoperative day 4 ]
    The BPI is a 15-item, validated patient-reported outcome measure used to assess pain severity.

  6. Brief Pain Inventory (BPI) Score [ Time Frame: Average BPI score will be collected for postoperative day 5 ]
    The BPI is a 15-item, validated patient-reported outcome measure used to assess pain severity.

  7. Brief Pain Inventory (BPI) Score [ Time Frame: Average BPI score will be collected for postoperative day 6 ]
    The BPI is a 15-item, validated patient-reported outcome measure used to assess pain severity.

  8. Brief Pain Inventory (BPI) Score [ Time Frame: Average BPI score will be collected for postoperative day 7 ]
    The BPI is a 15-item, validated patient-reported outcome measure used to assess pain severity.

  9. Severity of epistaxis [ Time Frame: Epistaxis severity will be collected at the preoperative visit ]
    The severity of epistaxis will be recorded using a VAS score ranging from "No bleeding" to "continuous bleeding."

  10. Severity of epistaxis [ Time Frame: Epistaxis severity will be collected for postoperative day 1 ]
    The severity of epistaxis will be recorded using a VAS score ranging from "No bleeding" to "continuous bleeding."

  11. Severity of epistaxis [ Time Frame: Epistaxis severity will be collected for postoperative day 2 ]
    The severity of epistaxis will be recorded using a VAS score ranging from "No bleeding" to "continuous bleeding."

  12. Severity of epistaxis [ Time Frame: Epistaxis severity will be collected for postoperative day 3 ]
    The severity of epistaxis will be recorded using a VAS score ranging from "No bleeding" to "continuous bleeding."

  13. Severity of epistaxis [ Time Frame: Epistaxis severity will be collected for postoperative day 4 ]
    The severity of epistaxis will be recorded using a VAS score ranging from "No bleeding" to "continuous bleeding."

  14. Severity of epistaxis [ Time Frame: Epistaxis severity will be collected for postoperative day 5 ]
    The severity of epistaxis will be recorded using a VAS score ranging from "No bleeding" to "continuous bleeding."

  15. Severity of epistaxis [ Time Frame: Epistaxis severity will be collected for postoperative day 6 ]
    The severity of epistaxis will be recorded using a VAS score ranging from "No bleeding" to "continuous bleeding."

  16. Severity of epistaxis [ Time Frame: Epistaxis severity will be collected for postoperative day 7 ]
    The severity of epistaxis will be recorded using a VAS score ranging from "No bleeding" to "continuous bleeding."



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.


Layout table for eligibility information
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


Contacts
Layout table for location contacts
Contact: Noel F Ayoub, MD MBA (650) 725-6500 nfa@stanford.edu
Contact: Peter Hwang, MD hwangph@stanford.edu

Locations
Layout table for location information
United States, California
Stanford Health Care Recruiting
Stanford, California, United States, 94305
Contact: Noel F Ayoub, MD MBA       nfa@stanford.edu   
Principal Investigator: Peter H Hwang, MD         
United States, Illinois
NorthShore University Health System Not yet recruiting
Evanston, Illinois, United States, 60201
Contact: Gnathan Carpenter, RN BSN         
Principal Investigator: Joseph Raviv, MD         
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Melanie Thompson, CCRP         
Principal Investigator: Garret Choby, MD         
United States, New York
Albert Einstein Not yet recruiting
Bronx, New York, United States, 10461
Contact: Sharan Shah         
Principal Investigator: Waleed Abuzeid, MD         
United States, Tennessee
Vanderbilt Recruiting
Nashville, Tennessee, United States, 37232
Contact: Cindy Dorminy         
Principal Investigator: Justin Turner, MD         
Canada
University of British Columbia Not yet recruiting
Vancouver, Canada
Contact: Sara Derikvand         
Principal Investigator: Andrew Thamboo, MD         
Sponsors and Collaborators
Stanford University
Mayo Clinic
Vanderbilt University Medical Center
Albert Einstein College of Medicine
University of British Columbia
NorthShore University HealthSystem
Publications:
Layout table for additonal information
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
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
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