Regional Anesthesia to Reduce Opioid Use Following Functional Endoscopic Sinus Surgery
The Role of Regional Anesthesia to Reduce Opioid Requirements Following Functional Endoscopic Sinus Surgery (FESS)
1 other identifier
interventional
46
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2018
CompletedFirst Posted
Study publicly available on registry
November 29, 2018
CompletedStudy Start
First participant enrolled
May 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 12, 2021
CompletedResults Posted
Study results publicly available
August 31, 2022
CompletedAugust 31, 2022
August 1, 2022
1.8 years
November 27, 2018
March 20, 2022
August 12, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Opioid Medication Use
10 days
Study Arms (2)
Treatment Group
EXPERIMENTAL20 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
Control Group
NO INTERVENTIONNo regional anesthetic of any kind during the functional endoscopic sinus surgery (FESS) procedure
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jessica W. Grayson
- Organization
- UAB
Study Officials
- PRINCIPAL INVESTIGATOR
Brad Woodworth, MD
University of Alabama at Birmingham
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 27, 2018
First Posted
November 29, 2018
Study Start
May 20, 2019
Primary Completion
March 12, 2021
Study Completion
April 12, 2021
Last Updated
August 31, 2022
Results First Posted
August 31, 2022
Record last verified: 2022-08