Clinical trial NCT06450028: Lidocaine Versus Bupivacaine in Orthognathic Surgery
Official title: Lidocaine Versus Bupivacaine in Orthognathic Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pain, Postoperative
Numbness
Temperature Sensation
Perception of Touch
Keywords: orthognathic surgery
lidocaine
bupivacaine
Le Fort I
bilateral sagittal split osteotomy (BSSO)
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two groups. Group 1 will receive 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine on the left side of their jaw and 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine on the right side of their jaw. Group 2 will receive 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine on the right side of their jaw and 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine on the left side of their jaw.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Patient-reported pain
timeFrame: (1) four to six weeks prior to their orthognathic procedure, (2) approximately one hour after their orthognathic procedure, (3) approximately four hours after their orthognathic procedure, (4) one week after their orthognathic procedure.
Secondary outcomes:
measure: Numbness
timeFrame: (1) four to six weeks prior to their orthognathic procedure, (2) approximately one hour after their orthognathic procedure, (3) approximately four hours after their orthognathic procedure, (4) one week after their orthognathic procedure.
measure: Light Touch and Directionality Perception
timeFrame: (1) four to six weeks prior to their orthognathic procedure, (2) approximately one hour after their orthognathic procedure, (3) approximately four hours after their orthognathic procedure, (4) one week after their orthognathic procedure.
measure: Temperature Sensation
timeFrame: (1) four to six weeks prior to their orthognathic procedure, (2) approximately one hour after their orthognathic procedure, (3) approximately four hours after their orthognathic procedure, (4) one week after their orthognathic procedure.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital, Department of Plastic and Oral Surgery
name: Mark A Green, DDS, MD
role: PRINCIPAL_INVESTIGATOR
References: