Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2025-12-31 @ 11:55 AM
Study NCT ID:
NCT06450028
Status:
RECRUITING
Last Update Posted:
2025-05-21
First Post:
2024-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lidocaine Versus Bupivacaine in Orthognathic Surgery
Sponsor:
Boston Children's Hospital
Organization:
Study Overview
Official Title:
Lidocaine Versus Bupivacaine in Orthognathic Surgery: A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: