Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2025-12-26 @ 10:32 AM
NCT ID:
NCT06450028
Eligibility Criteria:
Inclusion Criteria:
* Undergoing an orthognathic procedure at Boston Children's Hospital
* Between the ages of 15 and 35 years old
Exclusion Criteria:
* Any patient undergoing any other procedures in addition to their orthognathic procedure during the same sedation period (extraction, bone graft, etc.).
* Any patient with a history of chronic pain.
* Any patient with a history of an allergic reaction to bupivacaine or lidocaine.
* Any patient with known neurologic changes to the lip or chin.
* Any patient not enrolled in an Enhanced Recovery After Surgery (ERAS) Protocol.
* Any patient known to be pregnant or with a positive pregnancy test prior to the procedure.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
35 Years
Study:
NCT06450028
Study Brief:
Protocol Section:
NCT06450028