A Phase 4 interventional study of 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine and 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine in Pain, Postoperative, Numbness and Temperature Sensation, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Open to participants aged 15 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Boston Children's Hospital · Phase 4, Interventional, and Treatment
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.
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 64 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
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Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
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Exclusion Criteria:
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. This dosage will be administered once as peripheral nerve blocks at the beginning of the participant's orthognathic procedure.
Drug: 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine · Drug: 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine
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. This dosage will be administered once as peripheral nerve blocks at the beginning of the participant's orthognathic procedure.
Drug: 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine · Drug: 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine
Drug page: Bupivacaine
Injection of 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine.
Also known as: Bupivacaine
Drug page: Lidocaine
Injection of 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine.
Also known as: Lidocaine
Patient-Reported Numbness
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.
Time frame: 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.
Number of Participants With Patient-Reported Numbness
Participants will be asked to whether or not they are numb on each side of their mandible/maxilla.
Time frame: 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.
Number of Participants With Overall Side Preference
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.
Time frame: 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.
Light Touch Perception
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).
Time frame: 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.
Directionality Perception
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.
Time frame: 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 Perception
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.
Time frame: 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.
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.
| Milestone | All Study Participants |
|---|---|
| Started | 64 |
| Received bupivacaine | 50 |
| Received lidocaine | 50 |
| Completed | 50 |
| Not completed | 14 |
| Withdrew: Procedure canceled/rescheduled | 4 |
| Withdrew: Additional procedure added | 9 |
| Withdrew: Withdrawal by subject | 1 |
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.
| Scores on a scale | Bupivacaine-Treated Side | Lidocaine-Treated Side |
|---|---|---|
| 2-Hours Post-Op | 3.12 ± 2.21 | 3.88 ± 2.29 |
| 4-Hours Post-Op | 3.53 ± 2.76 | 4.53 ± 2.58 |
| 1-Week Post-Op | 1.60 ± 1.88 | 1.58 ± 1.64 |
Participants will be asked to whether or not they are numb on each side of their mandible/maxilla.
| Participants | Bupivacaine-Treated Side | Lidocaine-Treated Side |
|---|---|---|
| 2-Hours Post-Op | 33 | 33 |
| 4-Hours Post-Op | 29 | 28 |
| 1-Week Post-Op | 41 | 37 |
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.
| Participants | Bupivacaine-Treated Side | Lidocaine-Treated Side |
|---|---|---|
| 2-Hours Post-Op | 10 | 2 |
| 4-Hours Post-Op | 15 | 2 |
| 1-Week Post-Op | 10 | 12 |
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).
| Grams | Bupivacaine-Treated Side | Lidocaine-Treated Side |
|---|---|---|
| 2-Hours Post-Op | 0.023 ± 0.070 | 0.023 ± 0.070 |
| 4-Hours Post-Op | 0.016 ± 0.018 | 0.015 ± 0.015 |
| 1-Week Post-Op | 0.009 ± 0.002 | 0.009 ± 0.009 |
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.
| Correct Identifications (out of 10) | Bupivacaine-Treated Side | Lidocaine-Treated Side |
|---|---|---|
| 2-Hours Post-Op | 8.90 ± 1.35 | 8.29 ± 1.66 |
| 4-Hours Post-Op | 7.24 ± 2.89 | 7.93 ± 2.17 |
| 1-Week Post-Op | 9.27 ± 1.48 | 9.27 ± 1.45 |
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.
| Correct Identifications (out of 5) | Bupivacaine-Treated Side | Lidocaine-Treated Side |
|---|---|---|
| 2-Hours Post-Op (Hot) | 3.26 ± 1.67 | 3.16 ± 1.73 |
| 2-Hours Post-Op (Cold) | 4.06 ± 1.61 | 4.23 ± 1.43 |
| 4-Hours Post-Op (Hot) | 3.34 ± 1.67 | 3.28 ± 1.65 |
| 4-Hours Post-Op (Cold) | 3.86 ± 1.66 | 3.79 ± 1.54 |
| 1-Week Post-Op (Hot) | 4.10 ± 1.15 | 4.25 ± 1.19 |
| 1-Week Post-Op (Cold) | 4.19 ± 1.27 | 4.21 ± 1.24 |
Collected over All subjects were monitored throughout the 3-month post-operative period for complications or adverse outcomes related to the study intervention.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bupivacaine-Treated Side | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Lidocaine-Treated Side | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
Each participant received both interventions on opposite jaw sides, with sides of jaw as the unit of assignment.
| Age, Continuous(Years) | All Study Participants |
|---|---|
| Median | 19.37 (17.00 to 21.49) |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 34 |
| Male | 30 |
| Race/Ethnicity, Customized(Participants) | All Study Participants |
|---|---|
| Asian, non-Hispanic | 9 |
| Hispanic | 4 |
| Other/Unknown | 19 |
| White, non-Hispanic | 32 |
| Procedure Type(Participants) | All Study Participants |
|---|---|
| LFI | 27 |
| BSSO | 8 |
| BiMax | 25 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Individual participant data (IPD) will not be available to other researchers.
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Studies of the drugs tested here: Bupivacaine · Lidocaine