Pain Control Following Sinus Surgery

NCT03783702 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 46384
• Study Type: interventional
• Target: 118
• Locations: 2 countries
• Sites: 6

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.

Conditions

Sinusitis; Opioid Use; Opioid Abuse; Narcotic Use; Otolaryngologic Disease; Postoperative Pain; Pain

Outcome Measures

Primary Outcomes (9)

• 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)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (16)

• Brief Pain Inventory (BPI) Score

  BPI score will be collected at the preoperative visit

• Brief Pain Inventory (BPI) Score

  Average BPI score will be collected for postoperative day 1

• Brief Pain Inventory (BPI) Score

  Average BPI score will be collected for postoperative day 2

• Brief Pain Inventory (BPI) Score

  Average BPI score will be collected for postoperative day 3

• Brief Pain Inventory (BPI) Score

  Average BPI score will be collected for postoperative day 4

Study Arms (2)

Experimental group

EXPERIMENTAL

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; Drug: Ibuprofen 600 Mg (milligram) Oral Tablet; Drug: Acetaminophen 650 MG (milligram) Oral Tablet

Control group

ACTIVE COMPARATOR

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; Drug: Acetaminophen 650 MG (milligram) Oral Tablet

Interventions

OxyCODONE 5 Mg (milligram) Oral Tablet DRUG

Oxycodone will be the second-line treatment in the control group and the third-line treatment in the experimental group.

Control group; Experimental group

Ibuprofen 600 Mg (milligram) Oral Tablet DRUG

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

Experimental group

Acetaminophen 650 MG (milligram) Oral Tablet DRUG

All patients will receive acetaminophen as the first-line analgesic.

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• Mayo Clinic: collaborator
• Vanderbilt University Medical Center: collaborator
• Albert Einstein College of Medicine: collaborator
• University of British Columbia: collaborator
• Endeavor Health: collaborator

Study Sites (6)

Stanford Health Care

Stanford, California, 94305, United States

Location

NorthShore University Health System

Evanston, Illinois, 60201, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Albert Einstein

The Bronx, New York, 10461, United States

Location

Vanderbilt

Nashville, Tennessee, 37232, United States

Location

University of British Columbia

Vancouver, Canada

Location

Related Publications (5)

• 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.

  PMID: 20058315 BACKGROUND

• 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.

  PMID: 29460670 BACKGROUND

• 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.

  PMID: 29446449 BACKGROUND

• 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.

  PMID: 29557264 BACKGROUND

• 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.

  PMID: 34351376 DERIVED

MeSH Terms

Conditions

Sinusitis; Opioid-Related Disorders; Otorhinolaryngologic Diseases; Pain, Postoperative; Pain

Interventions

Oxycodone; Magnesium; Tablets; Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals; Dosage Forms; Pharmaceutical Preparations; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Limitations and Caveats

The low levels of narcotic consumption observed may have precluded achieving significance in pain score comparisons across groups, as the pre-hoc power analysis predicted higher levels of opioid use Selection bias: 1) patient willingness to participate in an opioid-related study could serve as a source of bias 2) loss to follow up Lack of blinding and placebo were additional limitations

Results Point of Contact

• Title: Noel Ayoub
• Organization: Stanford University School of Medicine

nfa@stanford.edu

3109407055

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor

Model Details: Patients will be randomized into one of two groups: one will receive acetaminophen and oxycodone while the other will receive acetaminophen, ibuprofen, and oxycodone.

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 21, 2018
• Study Start: April 4, 2019
• Primary Completion: July 1, 2020
• Study Completion: December 30, 2020
• Last Updated: September 1, 2021
• Results First Posted: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (5)