Pain Control Following Sinus Surgery

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-04

Study Completion Date

2020-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

OxyCODONE 5 Mg (milligram) Oral Tablet

Intervention Type DRUG

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

Ibuprofen 600 Mg (milligram) Oral Tablet

Intervention Type DRUG

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

Acetaminophen 650 MG (milligram) Oral Tablet

Intervention Type DRUG

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

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).

Group Type ACTIVE_COMPARATOR

OxyCODONE 5 Mg (milligram) Oral Tablet

Intervention Type DRUG

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

Acetaminophen 650 MG (milligram) Oral Tablet

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Ibuprofen 600 Mg (milligram) Oral Tablet

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

Intervention Type DRUG

Acetaminophen 650 MG (milligram) Oral Tablet

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No