Regional Anesthesia to Reduce Opioid Use Following FESS



Status:Not yet recruiting
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:April 2019
End Date:April 2022
Contact:Norma Miller, RN
Email:ncmiller@uabmc.edu
Phone:205-934-9714

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

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.

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.

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
We found this trial at
1
site
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Brad Woodworth, MD
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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from
Birmingham, AL
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