Regional Anesthesia to Reduce Opioid Use Following Functional Endoscopic Sinus Surgery

Pain Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03757715
• Other study ID #: IRB-300000567
• Status: Completed
• Phase: Phase 4
• Start date: May 20, 2019
• Est. completion date: April 12, 2021

Study information

• Verified date: August 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 12, 2021
• Est. primary completion date: March 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain Management

Intervention

Drug:
• Bupivacaine
20 mL of 1.3% bupivacaine
• Dexamethasone
2 mg dexamethasone

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Pain Control	Self-report of pain score on a scale of 0 to 10, with 0 being "no pain" and 10 being "worst pain imaginable"	10 days
Secondary	Opioid Medication Use	Amount of opioid medication used, based on pill count	10 days