Phase 4
N=46
Regional Anesthesia to Reduce Opioid Use Following Functional Endoscopic Sinus Surgery
Pain Management
Bottom Line
View on ClinicalTrials.gov: NCT03757715 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: Participant Pain Control — 4.5; 5.87; 4.63; 5.00 units on a scale — p=0.16
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bupivacaine (Drug); Dexamethasone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant Pain Control |
4.5; 5.87; 4.63; 5.00; 4.06; 4.13 | 0.16 |
| SECONDARY Opioid Medication Use |
1.38; 1.07; 2.31; 1.87; 1.69; 1.40 | 0.42 |
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.
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
Data sourced from ClinicalTrials.gov (NCT03757715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.