drugset / Trial / NCT03757715
Regional Anesthesia to Reduce Opioid Use Following Functional Endoscopic Sinus Surgery
RandomizedParallel-groupSingle-blindSupportive care
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.
Timeline
- Start
- 2019-05-20
- Primary completion
- 2021-03-12
- Completion
- 2021-04-12
Outcome
Missed primary endpoint
registry analysis (superiority test); Treatment Group vs Control Group; p = 0.16; t-test, 1 sided NCT03757715 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupivacaine | Other / unclassified | 1.3 % | Other |
| Subject | Bupivacaine | Other / unclassified | 20 ml | Other |
| Subject | Dexamethasone | Small molecule | 2 mg | Other |
Indications
No indication recorded.