Regional Anesthesia to Reduce Opioid Use Following Functional Endoscopic Sinus Surgery

NCT ID: NCT03757715

Last Updated: 2022-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-20
• Study Completion Date: 2021-04-12

Brief 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.

Detailed 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.

Conditions

Pain Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Treatment Group

20 mL of 1.3% bupivacaine with 2 mg dexamethasone injected locally in the location for sensory nerves of the sinus cavities and face during the functional endoscopic sinus surgery (FESS) procedure

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

20 mL of 1.3% bupivacaine

Dexamethasone

Intervention Type: DRUG

2 mg dexamethasone

Control Group

No regional anesthetic of any kind during the functional endoscopic sinus surgery (FESS) procedure

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bupivacaine

20 mL of 1.3% bupivacaine

Intervention Type: DRUG

Dexamethasone

2 mg dexamethasone

Intervention Type: DRUG

Other Intervention Names

Marcaine; Ozurdex

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Brad Woodworth, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brad Woodworth, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

IRB-300000567

Identifier Type: -

Identifier Source: org_study_id