Pain, PostoperativePhase 4NCT06450028
Lidocaine Versus Bupivacaine in Orthognathic Surgery
A Phase 4 study testing 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 people with Pain, Postoperative and Numbness, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Numbness, Temperature Sensation
- What is being tested?
- 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 30 Nov 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Undergoing an orthognathic procedure at Boston Children's Hospital
- Between the ages of 15 and 35 years old
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Lidocaine Versus Bupivacaine in Orthognathic Surgery: A Randomized Controlled Trial
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.
Read the 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.
- Being tested
- 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine, 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine
- Keywords
- orthognathic surgery, lidocaine, bupivacaine, Le Fort I, bilateral sagittal split osteotomy (BSSO)
- Medical subject headings
- Pain, Postoperative, Hypesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrineDrug
Also called Bupivacaine
Injection of 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine.
6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrineDrug
Also called Lidocaine
Injection of 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine Left, Lidocaine Right | Active comparator | 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. Receives: 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 |
| Bupivacaine Right, Lidocaine Left | Active comparator | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 Oct 2024
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Green, Boston Children's Hospital
- Investigators
- Mark A Green, DDS, MD, Principal investigator, Boston Children's Hospital, Department of Plastic and Oral Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450028
- Sponsor's protocol ID
- IRB-P00047452
- Status last verified
- Jul 2026
- First submitted
- 4 Jun 2024
- Last updated
- 4 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine Versus Bupivacaine in Orthognathic Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06450028
- Acronym / sponsor ID
- IRB-P00047452
- Keywords
- orthognathic surgery, lidocaine, bupivacaine, Le Fort I, bilateral sagittal split osteotomy (BSSO)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 10 Jun 2024 (actual)
- Results
- Posted 14 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine Left, Lidocaine Right | Active comparator | 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 epinephrineGroup 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. |
| Bupivacaine Right, Lidocaine Left | Active comparator | 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 epinephrineGroup 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. |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Undergoing an orthognathic procedure at Boston Children's Hospital
- Between the ages of 15 and 35 years old
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrineAlso: BupivacaineInjection of 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine. | Drug | Bupivacaine Left, Lidocaine Right, Bupivacaine Right, Lidocaine Left |
| 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrineAlso: LidocaineInjection of 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine. | Drug | Bupivacaine Left, Lidocaine Right, Bupivacaine Right, Lidocaine Left |
Primary outcome
Patient-Reported Numbness
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.
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.
5 secondary outcomes
Number of Participants With Patient-Reported Numbness
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
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
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
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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Lidocaine - StatPearlsLink provided by the sponsor.
- Bupivacaine - StatPearlsLink provided by the sponsor.
- Bader JD, Bonito AJ, Shugars DA. Cardiovascular Effects of Epinephrine in Hypertensive Dental Patients: Summary.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A Green, DDS, MD principal investigator
Boston Children's Hospital, Department of Plastic and Oral Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 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 people with Pain, Postoperative and Numbness, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Numbness (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.