Numbness, Pain, Postoperative, Perception of Touch, Temperature Sensation
Conditions
Keywords
orthognathic surgery, lidocaine, bupivacaine, Le Fort I, bilateral sagittal split osteotomy (BSSO)
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.
Interventions
DRUG10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine
Injection of 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine.
DRUG6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine
Injection of 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine.
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The participant will not know which anesthetic they received on each side of their jaw. The care provider, who will be administering the anesthetic intraoperatively, will know which anesthetic is being administered on each side of the participant's jaw. The outcomes assessor will not know which anesthetics was administered on each side of the participant's jaw.
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.
Eligibility
Sex/Gender
ALL
Age
15 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Numbness | Outcome measures were assessed (1) approximately 2 hours after each subject's orthognathic procedure, (2) approximately four hours after each subject's orthognathic procedure, and (3) approximately one week after each subject's orthognathic procedures. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Patient-Reported Numbness | Outcome measures were assessed (1) approximately 2 hours after each subject's orthognathic procedure, (2) approximately four hours after each subject's orthognathic procedure, and (3) approximately one week after each subject's orthognathic procedures. | Participants will be asked to whether or not they are numb on each side of their mandible/maxilla. |
| Number of Participants With Overall Side Preference | Outcome measures were assessed (1) approximately 2 hours after each subject's orthognathic procedure, (2) approximately four hours after each subject's orthognathic procedure, and (3) approximately one week after each subject's orthognathic procedures. | Overall preference was recorded by asking subjects to indicate whether they preferred one side of their face or had no preference, considering pain, numbness, and sensation. |
| Light Touch Perception | Outcome measures were assessed (1) approximately 2 hours after each subject's orthognathic procedure, (2) approximately four hours after each subject's orthognathic procedure, and (3) approximately one week after each subject's orthognathic procedures. | Participants will be tested regarding their perception of light touch using Von Frey hairs (Baseline Evaluation Instruments). Von Frey hairs are standardized plastic filaments that are numbered numerically representing the weight in grams that it takes to bend the filament. The smallest perceivable filament size was recorded, with a smaller size indicating a higher degree of perception (minimum: 0.008 g, maximum: 300 g). |
| Directionality Perception | Outcome measures were assessed (1) approximately 2 hours after each subject's orthognathic procedure, (2) approximately four hours after each subject's orthognathic procedure, and (3) approximately one week after each subject's orthognathic procedures. | Participants will be tested regarding their perception of directionality using Von Frey hairs (Baseline Evaluation Instruments). Von Frey hairs are standardized plastic filaments that are numbered numerically representing the weight in grams that it takes to bend the filament. The number of correctly identified directionality (left/right vs. up/down) measures out of 10 was recorded. |
| Temperature Perception | Outcome measures were assessed (1) approximately 2 hours after each subject's orthognathic procedure, (2) approximately four hours after each subject's orthognathic procedure, and (3) approximately one week after each subject's orthognathic procedures. | Temperature sensation will be assessed by application of warm and cold water to mandible/maxilla using cotton tip applicators. Participants will be prompted to describe the temperature of the sensation they are experiencing. The number of correctly identified temperatures (hot vs. cold) out of 5 was recorded. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMark A Green, DDS, MD
Boston Children's Hospital, Department of Plastic and Oral Surgery
Participant flow
Recruitment details
Subjects were enrolled at orthognathic work-up appointments between October 1, 2024, and August 1, 2025. Subjects were included if they were between the ages of 15 and 35 years and were undergoing an orthognathic procedure.
Pre-assignment details
After randomization, subjects across both groups were excluded prior to their operation due to a canceled/rescheduled procedure, an additional procedure added to their orthognathic operation, or a withdrawn consent, as described in the Participant Flow. The remaining study participants received the allocated intervention and were assessed post-operatively.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 19.37 Years |
| Procedure Type BiMax | 25 Participants |
| Procedure Type BSSO | 8 Participants |
| Procedure Type LFI | 27 Participants |
| Race/Ethnicity, Customized Asian, non-Hispanic | 9 Participants |
| Race/Ethnicity, Customized Hispanic | 4 Participants |
| Race/Ethnicity, Customized Other/Unknown | 19 Participants |
| Race/Ethnicity, Customized White, non-Hispanic | 32 Participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
None listed