Pain Control Following Sinus Surgery

• ClinicalTrials.gov Identifier: NCT03783702
• Recruitment Status: Recruiting
• First Posted: December 21, 2018
• Last Update Posted: September 20, 2019
• 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 Oral Tablet; Drug: Ibuprofen 600 Mg Oral Tablet; Drug: Acetaminophen 650 MG Oral Tablet	Phase 4

Study Design

• 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

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 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.

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 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."

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

Contacts

Contact: Noel F Ayoub, MD MBA; (650) 725-6500; nfa@stanford.edu

Contact: Peter Hwang, MD; hwangph@stanford.edu

Locations

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

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.

• Responsible Party: Peter Hwang, Principal Investigator, Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT03783702
• Other Study ID Numbers: 46384
• First Posted: December 21, 2018
• Last Update Posted: September 20, 2019
• Last Verified: September 2019

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; 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