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NCT06450028 · ClinicalTrials.gov registry record · Phase 4
Lidocaine Versus Bupivacaine in Orthognathic Surgery
A Phase 4 study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT06450028: Completed Phase 4 study, sponsored by Boston Children's Hospital.
NCT06450028 is a Phase 4 study that has completed, run by Boston Children's Hospital. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06450028, a Phase 4 study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study Summary
In this research study, we want to learn more about the impact of two different local anesthetics (bupivacaine and lidocaine) on patient experience following orthognathic (jaw) surgery. Both anesthetics are within the standard of care for dental and orthognathic procedures, but can vary in how quickly they take action and how long they last. This study will provide us with a greater understanding of how anesthetic choice affect patient outcomes, and how we can strive to make these outcomes as favorable as possible.
Primary Outcome
Pain will be measured by prompting participants to rank their pain on a scale (minimum 1, maximum 10; 1 meaning minimal pain and 10 meaning maximum pain) on each side of their mandible/maxilla.
Interventions
- DRUG 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine
- DRUG 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-07-26 |
| Est. Completion | 2025-11-30 |
| Phase | Phase 4 |
What the finished NCT06450028 record still lists
NCT06450028 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine is the first listed.
NCT06450028 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06450028 about?
NCT06450028 is a clinical study titled "Lidocaine Versus Bupivacaine in Orthognathic Surgery". In this research study, we want to learn more about the impact of two different local anesthetics (bupivacaine and lidocaine) on patient experience following orthognathic (jaw) surgery. Both anesthetics are within the standard of care for dental and orthognathic procedures, but can vary in how quick...
What is the current status of trial NCT06450028?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2024-07-26. Estimated completion is 2025-11-30.
What interventions are being tested in trial NCT06450028?
The interventions under investigation include: 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine (DRUG), 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine (DRUG).
Who is sponsoring clinical trial NCT06450028?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06450028's enrollment target sits among peer trials
60 1125th of 2000 higher than 799 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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