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Completed

NCT Number: NCT03757715

Regional Anesthesia to Reduce Opioid Use Following Functional Endoscopic Sinus Surgery

Opioids are prescribed for moderate to severe pain disorders; however, there are contraindications and side effects that are common to all opioids. The investigators hypothesize using regional anesthetic during sinus surgery will reduce surgical pain, therefore decreasing the need for post-operative opioid medication. The primary of objective is to determine if a long-acting local regional anesthetic applied during a surgery will reduce post-operative oral opioid usage.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

About this study

Opioid analgesics are prescribed for moderate to severe acute pain; however, there are contraindications, cautions, and side effects that are common with all opioids. Dependence and tolerance are also likely with regular opioid use, resulting in the current nationwide opioid epidemic. In Alabama alone, there were 343 opioid-related overdose deaths in 2016, 124 of which were related to prescription opioids. Alabama providers have the highest prescribing rate in the country, nearly twice the national rate, per the NIH/NIDA website. In 2015, the Centers for Disease Control (CDC) released prescribing guidelines relating to chronic pain, and in 2018 Alabama's Blue Cross/Blue Shield insurance group limited the supply of opioids allowed to their members to 7 days.

There is currently no clinical guideline for prescribing post operative opioid medications for functional endoscopic sinus surgery (FESS). A 2018 survey documenting prescribing patterns by 168 members of the American Rhinologic Society found that most physicians who participated prescribed, on average, 27 opioid pain pills for patients after surgery. Prior studies have been performed to help decrease the pain patient's feel after sinus surgery. Haytoglu in 2016 revealed that adding non-absorbable sinus packs loaded with local anesthetics such as bupivacaine achieved less pain values and improved patient satisfaction scores.

Given this current data the investigators believe injecting patients with a long acting analgesic during the procedure will help reduce post-operative pain. If the investigators can decrease the amount of pain patients have in the post-operative period, they can theoretically decrease the number of opioid pain pills prescribed. The investigators plan to also track the number of opioid pills consumed by patients in the post-operative period to obtain a somewhat uniform prescribing pattern within surgeons.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older
  • Able to sign informed consent form
  • Able to comply with all study procedures and availability for the duration of the study
  • Able to speak English
  • Diagnosis of chronic rhinosinusitis
  • Scheduled to receive functional endoscopic sinus surgery (FESS) at UAB

Exclusion criteria

  • Current use of opioid medication
  • Known allergic reactions to components of the study intervention
  • History of IV drug use or abuse
  • History of opioid abuse
  • History of chronic pain disorder
  • Treatment with another investigational drug or other intervention within 30 days

Treatment and study plan

Bupivacaine

Drug

20 mL of 1.3% bupivacaine

Other names: Marcaine

Dexamethasone

Drug

2 mg dexamethasone

Other names: Ozurdex

Primary outcomes

  1. Participant Pain Control

    Time frame: 10 days

    Self-report of pain score on a scale of 0 to 10, with 0 being "no pain" and 10 being "worst pain imaginable"

Secondary outcomes

  1. Opioid Medication Use

    Time frame: 10 days

    Amount of opioid medication used, based on pill count

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

The Role of Regional Anesthesia to Reduce Opioid Requirements Following Functional Endoscopic Sinus Surgery (FESS)

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 29, 2018
Registry last updated
Aug 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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