Lidocaine Versus Bupivacaine in Orthognathic Surgery

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Numbness; Temperature Sensation; Perception of Touch
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 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.; Other Names: Bupivacaine; Drug: 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 Names: Lidocaine
Active Comparator: 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.	Drug: 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.; Other Names: Bupivacaine; Drug: 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 Names: Lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported pain	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. Patients will also be asked to subjectively describe their pain experiences on each side of their mandible/maxilla.	(1) four to six weeks prior to their orthognathic procedure, (2) approximately one hour after their orthognathic procedure, (3) approximately four hours after their orthognathic procedure, (4) one week after their orthognathic procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numbness	Participants will be asked to describe their feelings of numbness on a scale (minimum 1, maximum 10; 1 meaning minimal pain and 10 meaning maximum pain) on each side of their mandible/maxilla.	(1) four to six weeks prior to their orthognathic procedure, (2) approximately one hour after their orthognathic procedure, (3) approximately four hours after their orthognathic procedure, (4) one week after their orthognathic procedure.
Light Touch and Directionality Perception	Participants will be tested regarding their perception of light touch using Von Frey hairs. Von Frey hairs are standardized plastic filaments that are numbered numerically representing the weight in grams that it takes to bend the filament. Von Frey's hairs will also be used to assess perception of directionality.	(1) four to six weeks prior to their orthognathic procedure, (2) approximately one hour after their orthognathic procedure, (3) approximately four hours after their orthognathic procedure, (4) one week after their orthognathic procedure.
Temperature Sensation	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.	(1) four to six weeks prior to their orthognathic procedure, (2) approximately one hour after their orthognathic procedure, (3) approximately four hours after their orthognathic procedure, (4) one week after their orthognathic procedure.

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Mark A Green, DDS, MD, Boston Children's Hospital, Department of Plastic and Oral Surgery

Publications and helpful links

Helpful Links

• Lidocaine - StatPearls
• Bupivacaine - StatPearls
• Bupivacaine - Mayo Clinic
• Bader JD, Bonito AJ, Shugars DA. Cardiovascular Effects of Epinephrine in Hypertensive Dental Patients: Summary.

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2024
• Primary Completion (Actual): November 30, 2025
• Study Completion (Actual): November 30, 2025

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: lidocaine; bupivacaine; orthognathic surgery; Le Fort I; bilateral sagittal split osteotomy (BSSO)
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Sensation Disorders; Somatosensory Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Hypesthesia; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Catechols; Phenols; Benzene Derivatives; Alcohols; Amino Alcohols; Ethanolamines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Bupivacaine; Lidocaine; Epinephrine
• Other Study ID Numbers: IRB-P00047452

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes