Trial Outcomes & Findings for Lidocaine Versus Bupivacaine in Orthognathic Surgery (NCT NCT06450028)
NCT ID: NCT06450028
Last Updated: 2026-08-04
Results Overview
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.
COMPLETED
PHASE4
64 participants
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.
2026-08-04
Participant Flow
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.
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operation due to a canceled/rescheduled procedure, an additional procedure added to their orthognathic operation, or a withdrawn consent, as described in the Participant Flow.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.
Unit of analysis: Sides of jaw
Participant milestones
| Measure |
All Study Participants
All participants received both local anesthetic interventions during their orthognathic procedure. A computerized random number generator was used to determine which side of the jaw received each intervention. One side of the jaw received 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine, and the contralateral side received 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine. The interventions were administered once as peripheral nerve blocks at the beginning of the procedure.
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|---|---|
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Overall Study
STARTED
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64 128
|
|
Overall Study
Received bupivacaine
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50 50
|
|
Overall Study
Received lidocaine
|
50 50
|
|
Overall Study
COMPLETED
|
50 100
|
|
Overall Study
NOT COMPLETED
|
14 28
|
Reasons for withdrawal
| Measure |
All Study Participants
All participants received both local anesthetic interventions during their orthognathic procedure. A computerized random number generator was used to determine which side of the jaw received each intervention. One side of the jaw received 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine, and the contralateral side received 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine. The interventions were administered once as peripheral nerve blocks at the beginning of the procedure.
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|---|---|
|
Overall Study
Procedure canceled/rescheduled
|
4
|
|
Overall Study
Additional procedure added
|
9
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Calculated excluding subjects (n=4) with canceled/rescheduled procedures.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=128 Sides of jaw
All participants received both local anesthetic interventions during their orthognathic procedure. A computerized random number generator was used to determine which side of the jaw received each intervention. One side of the jaw received 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine, and the contralateral side received 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine. The interventions were administered once as peripheral nerve blocks at the beginning of the procedure.
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|---|---|
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Age, Continuous
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19.37 Years
n=64 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Asian, non-Hispanic
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9 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Hispanic
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4 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Other/Unknown
|
19 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
32 Participants
n=64 Participants
|
|
Procedure Type
LFI
|
27 Participants
n=60 Participants • Calculated excluding subjects (n=4) with canceled/rescheduled procedures.
|
|
Procedure Type
BSSO
|
8 Participants
n=60 Participants • Calculated excluding subjects (n=4) with canceled/rescheduled procedures.
|
|
Procedure Type
BiMax
|
25 Participants
n=60 Participants • Calculated excluding subjects (n=4) with canceled/rescheduled procedures.
|
PRIMARY outcome
Timeframe: 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.Population: Data at specific post-operative timepoints was not collected if a subject was asleep, unable to communicate, refused participation, or was previously discharged.
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.
Outcome measures
| Measure |
Bupivacaine-Treated Side
n=50 Participants
This side of the jaw received 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine. The intervention was administered once as a peripheral nerve block at the beginning of the participant's orthognathic procedure.
|
Lidocaine-Treated Side
n=50 Participants
This side of the jaw received 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine. The intervention was administered once as a peripheral nerve block at the beginning of the participant's orthognathic procedure.
|
|---|---|---|
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Patient-Reported Numbness
2-Hours Post-Op
|
3.12 Scores on a scale
Standard Deviation 2.21
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3.88 Scores on a scale
Standard Deviation 2.29
|
|
Patient-Reported Numbness
4-Hours Post-Op
|
3.53 Scores on a scale
Standard Deviation 2.76
|
4.53 Scores on a scale
Standard Deviation 2.58
|
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Patient-Reported Numbness
1-Week Post-Op
|
1.60 Scores on a scale
Standard Deviation 1.88
|
1.58 Scores on a scale
Standard Deviation 1.64
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SECONDARY outcome
Timeframe: 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.Population: Data at specific post-operative timepoints was not collected if a subject was asleep, unable to communicate, refused participation, or was previously discharged.
Participants will be asked to whether or not they are numb on each side of their mandible/maxilla.
Outcome measures
| Measure |
Bupivacaine-Treated Side
n=50 Participants
This side of the jaw received 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine. The intervention was administered once as a peripheral nerve block at the beginning of the participant's orthognathic procedure.
|
Lidocaine-Treated Side
n=50 Participants
This side of the jaw received 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine. The intervention was administered once as a peripheral nerve block at the beginning of the participant's orthognathic procedure.
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|---|---|---|
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Number of Participants With Patient-Reported Numbness
2-Hours Post-Op
|
33 Participants
|
33 Participants
|
|
Number of Participants With Patient-Reported Numbness
4-Hours Post-Op
|
29 Participants
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28 Participants
|
|
Number of Participants With Patient-Reported Numbness
1-Week Post-Op
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41 Participants
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37 Participants
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SECONDARY outcome
Timeframe: 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.Population: The number of participants able to participate at each time point was dictated on their ability to participate and/or availability at each time point. Subjects unavailable for one time point (i.e. due to somnolence following anesthesia) were still able to participate at other time points
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.
Outcome measures
| Measure |
Bupivacaine-Treated Side
n=50 Participants
This side of the jaw received 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine. The intervention was administered once as a peripheral nerve block at the beginning of the participant's orthognathic procedure.
|
Lidocaine-Treated Side
n=50 Participants
This side of the jaw received 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine. The intervention was administered once as a peripheral nerve block at the beginning of the participant's orthognathic procedure.
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|---|---|---|
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Number of Participants With Overall Side Preference
4-Hours Post-Op
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15 Participants
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2 Participants
|
|
Number of Participants With Overall Side Preference
2-Hours Post-Op
|
10 Participants
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2 Participants
|
|
Number of Participants With Overall Side Preference
1-Week Post-Op
|
10 Participants
|
12 Participants
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SECONDARY outcome
Timeframe: 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.Population: Data at specific post-operative timepoints was not collected if a subject was asleep, unable to communicate, refused participation, or was previously discharged.
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).
Outcome measures
| Measure |
Bupivacaine-Treated Side
n=50 Participants
This side of the jaw received 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine. The intervention was administered once as a peripheral nerve block at the beginning of the participant's orthognathic procedure.
|
Lidocaine-Treated Side
n=50 Participants
This side of the jaw received 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine. The intervention was administered once as a peripheral nerve block at the beginning of the participant's orthognathic procedure.
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|---|---|---|
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Light Touch Perception
2-Hours Post-Op
|
0.023 Grams
Standard Deviation 0.070
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0.023 Grams
Standard Deviation 0.070
|
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Light Touch Perception
4-Hours Post-Op
|
0.016 Grams
Standard Deviation 0.018
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0.015 Grams
Standard Deviation 0.015
|
|
Light Touch Perception
1-Week Post-Op
|
0.009 Grams
Standard Deviation 0.002
|
0.009 Grams
Standard Deviation 0.009
|
SECONDARY outcome
Timeframe: 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.Population: Data at specific post-operative timepoints was not collected if a subject was asleep, unable to communicate, refused participation, or was previously discharged.
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.
Outcome measures
| Measure |
Bupivacaine-Treated Side
n=50 Participants
This side of the jaw received 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine. The intervention was administered once as a peripheral nerve block at the beginning of the participant's orthognathic procedure.
|
Lidocaine-Treated Side
n=50 Participants
This side of the jaw received 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine. The intervention was administered once as a peripheral nerve block at the beginning of the participant's orthognathic procedure.
|
|---|---|---|
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Directionality Perception
2-Hours Post-Op
|
8.90 Correct Identifications (out of 10)
Standard Deviation 1.35
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8.29 Correct Identifications (out of 10)
Standard Deviation 1.66
|
|
Directionality Perception
4-Hours Post-Op
|
7.24 Correct Identifications (out of 10)
Standard Deviation 2.89
|
7.93 Correct Identifications (out of 10)
Standard Deviation 2.17
|
|
Directionality Perception
1-Week Post-Op
|
9.27 Correct Identifications (out of 10)
Standard Deviation 1.48
|
9.27 Correct Identifications (out of 10)
Standard Deviation 1.45
|
SECONDARY outcome
Timeframe: 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.Population: Data at specific post-operative timepoints was not collected if a subject was asleep, unable to communicate, refused participation, or was previously discharged.
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.
Outcome measures
| Measure |
Bupivacaine-Treated Side
n=50 Participants
This side of the jaw received 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine. The intervention was administered once as a peripheral nerve block at the beginning of the participant's orthognathic procedure.
|
Lidocaine-Treated Side
n=50 Participants
This side of the jaw received 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine. The intervention was administered once as a peripheral nerve block at the beginning of the participant's orthognathic procedure.
|
|---|---|---|
|
Temperature Perception
2-Hours Post-Op (Hot)
|
3.26 Correct Identifications (out of 5)
Standard Deviation 1.67
|
3.16 Correct Identifications (out of 5)
Standard Deviation 1.73
|
|
Temperature Perception
2-Hours Post-Op (Cold)
|
4.06 Correct Identifications (out of 5)
Standard Deviation 1.61
|
4.23 Correct Identifications (out of 5)
Standard Deviation 1.43
|
|
Temperature Perception
4-Hours Post-Op (Hot)
|
3.34 Correct Identifications (out of 5)
Standard Deviation 1.67
|
3.28 Correct Identifications (out of 5)
Standard Deviation 1.65
|
|
Temperature Perception
4-Hours Post-Op (Cold)
|
3.86 Correct Identifications (out of 5)
Standard Deviation 1.66
|
3.79 Correct Identifications (out of 5)
Standard Deviation 1.54
|
|
Temperature Perception
1-Week Post-Op (Hot)
|
4.10 Correct Identifications (out of 5)
Standard Deviation 1.15
|
4.25 Correct Identifications (out of 5)
Standard Deviation 1.19
|
|
Temperature Perception
1-Week Post-Op (Cold)
|
4.19 Correct Identifications (out of 5)
Standard Deviation 1.27
|
4.21 Correct Identifications (out of 5)
Standard Deviation 1.24
|
Adverse Events
Bupivacaine-Treated Side
Lidocaine-Treated Side
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mark Green
Boston Children's Hospital, Department of Plastic and Oral Surgery
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place