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NCT04377204 · ClinicalTrials.gov registry record · Early Phase 1
The Utility of Long-acting Local Anesthetic Agents in Reducing Post-operative Opioid Requirements Following Rhinoplasty
A Early Phase 1 study, sponsored by Our Lady of the Lake Hospital.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 5
- Enrollment target
NCT04377204: Completed Early Phase 1 study, sponsored by Our Lady of the Lake Hospital.
NCT04377204 is a Early Phase 1 study that has completed, run by Our Lady of the Lake Hospital. The registered enrollment target is 5 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04377204, a Early Phase 1 study, has completed, sponsored by Our Lady of the Lake Hospital.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
On average, more than 130 Americans die every day from opioid overdose. Surgeons provide 37% of all opioid prescriptions in the United states, second only behind pain management physicians. A recent report found that patients who receive a 5-day supply of opioid medication have a 10% chance of using opioids 12 months later. Additionally, studies have shown that many opioid abusers are not the intended recipient, with over half diverting them from friends and family. Rhinoplasty is one of the most common procedures performed by facial plastic surgeons, with over 215,000 performed in the United States in 2017. Patients undergoing nasal surgery have been shown to be at significant risk for persistent and prolonged opioid use after filling an opioid prescription in the perioperative period. Thus, the management of postoperative pain without contributing to the opioid epidemic is a imperative. The first three days following nasal surgery are generally associated with considerable pain, with the highest levels occuring within the initial 24 hours. Published studies have demonstrated the benefit of non-opioid medications following rhinoplasty, such as pregabalin and celecoxib. There has also been growing recognition of the benefits of "pre-emptive analgesia," such as the use of local anesthesia, which not only helps control pain, but in turn decreases the anxiety caused by pain and can prevent patient turning to narcotics to break the cycle. These studies have predominantly focused on the immediate postoperative period, e.g. the first 24 hours. Currently, many surgeons use lidocaine with 1% epinephrine as local anesthesia for rhinoplasty due to its widespread availability, rapid time to onset, and safety profile. Several studies have shown the benefit of Marcaine bupivacaine over lidocaine for pain control and opioid consumption during the first 24 hours after surgery. This is not surprising, as the half-life of lidocaine is approximately 90 minutes in a healthy individ
Primary Outcome
Patients will record the frequency and number of oxycodone pills taken for pain up to 7 days post-op
Interventions
- DRUG Lidocaine
- DRUG marcaine bupivacaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2020-06-01 |
| Est. Completion | 2022-12-31 |
| Phase | Early Phase 1 |
What the finished NCT04377204 record still lists
NCT04377204 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Lidocaine is the first listed.
NCT04377204 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04377204 about?
NCT04377204 is a clinical study titled "The Utility of Long-acting Local Anesthetic Agents in Reducing Post-operative Opioid Requirements Following Rhinoplasty". On average, more than 130 Americans die every day from opioid overdose. Surgeons provide 37% of all opioid prescriptions in the United states, second only behind pain management physicians. A recent report found that patients who receive a 5-day supply of opioid medication have a 10% chance of using...
What is the current status of trial NCT04377204?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 5 participants. The study started on 2020-06-01. Estimated completion is 2022-12-31.
What interventions are being tested in trial NCT04377204?
The interventions under investigation include: Lidocaine (DRUG), marcaine bupivacaine (DRUG).
Who is sponsoring clinical trial NCT04377204?
This trial is sponsored by Our Lady of the Lake Hospital, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04377204's enrollment target sits among peer trials
5 1888th of 2000 higher than 80 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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