Phase 4
Completed N=46
Regional Anesthesia to Reduce Opioid Use Following Functional Endoscopic Sinus Surgery
Pain Management
Source: ClinicalTrials.gov NCT03757715 ↗
Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcomePrimary: Participant Pain Control — 4.5; 5.87; 4.63; 5.00 units on a scale — p=0.16
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 |
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. Informational only — not medical advice.