Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06450028 |
| Other study ID # |
IRB-P00047452 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
June 10, 2024 |
| Est. completion date |
July 1, 2025 |
Study information
| Verified date |
June 2024 |
| Source |
Boston Children's Hospital |
| Contact |
Michael C Britt |
| Phone |
6179192279 |
| Email |
michael.britt[@]childrens.harvard.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Aim 1: To determine if differences exist in patient-reported outcomes regarding the use of
bupivacaine and lidocaine in orthognathic surgery.
Aim 2: To assess patient experiences with pain, numbness, light touch perception, temperature
sensation and narcotic and pain medication consumption following administration of
bupivacaine and lidocaine in orthognathic surgery.
Lidocaine (known as lignospan commercially) and bupivacaine (known as marcaine or sensorcaine
commercially) are two local anesthetics used ubiquitously for procedures in the oral cavity.
Lidocaine is known for its fast-acting properties, which can take effect within one to two
minutes of administration. However, lidocaine also has a relatively short duration of action,
typically lasting about one to two hours. On the other hand, bupivacaine is slightly slower
acting (tales effect in 10-15 minutes) but has a much longer duration of action (up to eight
hours). Both local anesthetics are used in orthognathic surgery (jaw surgery) and are within
the standard of care for these procedures. Lidocaine and bupivacaine are both administered
with epinephrine as an additive to reduce bleeding in the operative field and improve the
depth and duration of anesthesia. Some patients may experience significant pain
postoperatively if their local anesthetic is metabolized too quickly, while others may
experience prolonged numbness and decreased sensation if their local anesthetic has too long
of a duration of action.
Patients will be randomized into two equally sized groups. Group 1 will receive 0.25%
bupivacaine hydrochloride and epinephrine 1:200,000 on the left side of their mandible and/or
maxilla and 2% lidocaine hydrochloride with 1:100,000 epinephrine on the right side of their
mandible and/or maxilla. Group 2 will receive 0.25% bupivacaine hydrochloride and epinephrine
1:200,000 on the right side of their mandible and/or maxilla and 2% lidocaine hydrochloride
with 1:100,000 epinephrine on the left side of their mandible and/or maxilla. The use of
bupivacaine and lidocaine are common practice in orthognathic surgery and are frequently used
in conjunction with each other. Email reminders will be sent to the oral surgeon reminding
them that their patients is enrolled in this study. Following that email, another email will
be sent to the oral surgeon by another individual to inform them of which side they are able
to administer which anesthetic. This allows the research staff member performing
postoperative assessments to remain blinded.
