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.
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.
Brief Title
Pain Control Following Sinus Surgery
Categories
Completion Date
Completion Date Type
Actual
Conditions
Sinusitis
Opioid Use
Opioid Abuse
Narcotic Use
Otolaryngologic Disease
Postoperative Pain
Pain
Eligibility 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.
* 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.
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03783702
Org Class
Other
Org Full Name
Stanford University
Org Study Id
46384
Overall Status
Completed
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Multi-institutional, Randomized Controlled Trial Assessing Opioid Use and Analgesic Requirements After Endoscopic Sinus Surgery
Primary Outcomes
Outcome Description
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.
Outcome Measure
Pain Severity
Outcome Time Frame
Average pain score will be collected for preoperative visit (the day before surgery)
Outcome Description
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.
Outcome Measure
Pain Severity
Outcome Time Frame
Average pain score was collected for postoperative day 1
Outcome Description
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.
Outcome Measure
Pain Severity
Outcome Time Frame
Average pain score will be collected for postoperative day 2
Outcome Description
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.
Outcome Measure
Pain Severity
Outcome Time Frame
Average pain score will be collected for postoperative day 3
Outcome Description
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.
Outcome Measure
Pain Severity
Outcome Time Frame
Average pain score will be collected for postoperative day 4
Outcome Description
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.
Outcome Measure
Pain Severity
Outcome Time Frame
Average pain score will be collected for postoperative day 5
Outcome Description
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.
Outcome Measure
Pain Severity
Outcome Time Frame
Average pain score will be collected for postoperative day 6
Outcome Description
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.
Outcome Measure
Pain Severity
Outcome Time Frame
Average pain score will be collected for postoperative day 7
Outcome Description
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.
Outcome Measure
Medication Log
Outcome Time Frame
Postoperative day 1 to 7
Secondary Outcomes
Outcome Description
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.
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.
Outcome Time Frame
BPI score will be collected at the preoperative visit
Outcome Measure
Brief Pain Inventory (BPI) Score
Outcome Description
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.
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.
Outcome Time Frame
Average BPI score will be collected for postoperative day 1
Outcome Measure
Brief Pain Inventory (BPI) Score
Outcome Description
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.
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.
Outcome Time Frame
Average BPI score will be collected for postoperative day 2
Outcome Measure
Brief Pain Inventory (BPI) Score
Outcome Description
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.
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.
Outcome Time Frame
Average BPI score will be collected for postoperative day 3
Outcome Measure
Brief Pain Inventory (BPI) Score
Outcome Description
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.
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.
Outcome Time Frame
Average BPI score will be collected for postoperative day 4
Outcome Measure
Brief Pain Inventory (BPI) Score
Outcome Description
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.
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.
Outcome Time Frame
Average BPI score will be collected for postoperative day 5
Outcome Measure
Brief Pain Inventory (BPI) Score
Outcome Description
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.
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.
Outcome Time Frame
Average BPI score will be collected for postoperative day 6
Outcome Measure
Brief Pain Inventory (BPI) Score
Outcome Description
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.
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.
Outcome Time Frame
Average BPI score will be collected for postoperative day 7
Outcome Measure
Brief Pain Inventory (BPI) Score
Outcome Description
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.
Outcome Time Frame
Epistaxis severity will be collected at the preoperative visit
Outcome Measure
Severity of Epistaxis
Outcome Description
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.
Outcome Time Frame
Epistaxis severity will be collected for postoperative day 1
Outcome Measure
Severity of Epistaxis
Outcome Description
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.
Outcome Time Frame
Epistaxis severity will be collected for postoperative day 2
Outcome Measure
Severity of Epistaxis
Outcome Description
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.
Outcome Time Frame
Epistaxis severity will be collected for postoperative day 3
Outcome Measure
Severity of Epistaxis
Outcome Description
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.
Outcome Time Frame
Epistaxis severity will be collected for postoperative day 4
Outcome Measure
Severity of Epistaxis
Outcome Description
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.
Outcome Time Frame
Epistaxis severity will be collected for postoperative day 5
Outcome Measure
Severity of Epistaxis
Outcome Description
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.
Outcome Time Frame
Epistaxis severity will be collected for postoperative day 6
Outcome Measure
Severity of Epistaxis
Outcome Description
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.
Outcome Time Frame
Epistaxis severity will be collected for postoperative day 7
Outcome Measure
Severity of Epistaxis
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Al-Waleed Abuzeid
Investigator Email
wabuzeid@montefiore.org
Investigator Phone