NCT03783702

Pain Control Following Sinus Surgery

Multi-institutional, Randomized Controlled Trial Assessing Opioid Use and Analgesic Requirements After Endoscopic Sinus Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.
DRUG	Ibuprofen 600 Mg (milligram) Oral Tablet	Patients in the experimental group will receive ibuprofen 600mg as the second-line analgesic.
DRUG	Acetaminophen 650 MG (milligram) Oral Tablet	All patients will receive acetaminophen as the first-line analgesic.

Timeline

• Start date: 2019-04-04
• Primary completion: 2020-07-01
• Completion: 2020-12-30
• First posted: 2018-12-21
• Last updated: 2021-09-01
• Results posted: 2021-09-01

Locations

6 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study