Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2024-07-26
2025-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Bupivacaine Left, Lidocaine Right
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.
10 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.
6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine
Injection of 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine.
Bupivacaine Right, Lidocaine Left
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.
10 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.
6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine
Injection of 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine.
Interventions
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10 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.
6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine
Injection of 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Between the ages of 15 and 35 years old
Exclusion Criteria
* 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.
15 Years
35 Years
ALL
Yes
Sponsors
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Boston Children's Hospital
OTHER
Responsible Party
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Mark Green
Oral and Maxillofacial Surgeon
Principal Investigators
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Mark A Green, DDS, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital, Department of Plastic and Oral Surgery
Locations
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Boston Children's Hospital
Boston, Massachusetts, United States
Countries
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Related Links
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Lidocaine - StatPearls
Bupivacaine - StatPearls
Bupivacaine - Mayo Clinic
Bader JD, Bonito AJ, Shugars DA. Cardiovascular Effects of Epinephrine in Hypertensive Dental Patients: Summary.
Other Identifiers
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IRB-P00047452
Identifier Type: -
Identifier Source: org_study_id