Lidocaine Versus Bupivacaine in Orthognathic Surgery

NCT06450028 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB-P00047452
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pain, Postoperative; Numbness; Temperature Sensation; Perception of Touch

Keywords

orthognathic surgery; lidocaine; bupivacaine; Le Fort I; bilateral sagittal split osteotomy (BSSO)

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

• Patient-Reported Numbness

  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.

• Overall Side Preference

  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

  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

  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

  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.

Study Arms (2)

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.

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.

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

Interventions

10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine DRUG

Injection of 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine.

Also known as: Bupivacaine

Bupivacaine Left, Lidocaine Right; Bupivacaine Right, Lidocaine Left

6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine DRUG

Injection of 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine.

Also known as: Lidocaine

Bupivacaine Left, Lidocaine Right; Bupivacaine Right, Lidocaine Left

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Undergoing an orthognathic procedure at Boston Children's Hospital
• Between the ages of 15 and 35 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Links

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

MeSH Terms

Conditions

Pain, Postoperative; Hypesthesia

Interventions

Bupivacaine; Epinephrine; Lidocaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Somatosensory Disorders; Sensation Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Acetanilides

Limitations and Caveats

While the sample size of this study is comparable to prior studies comparing local anesthetics in oral and maxillofacial surgery, it may be underpowered to detect subtle differences in neurosensory outcomes. Post-operative assessments were not completed for all participants, often due to somnolence or early discharge, which may have biased pain and sensory estimates. The single-institution design in adolescents and young adults may limit generalizability to other populations or settings.

Results Point of Contact

• Title: Mark Green
• Organization: Boston Children's Hospital, Department of Plastic and Oral Surgery

Mark.Green@childrens.harvard.edu

617-355-7252

Study Officials

• Mark A Green, DDS, MD

  Boston Children's Hospital, Department of Plastic and Oral Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participant will not know which anesthetic they received on each side of their jaw. The care provider, who will be administering the anesthetic intraoperatively, will know which anesthetic is being administered on each side of the participant's jaw. The outcomes assessor will not know which anesthetics was administered on each side of the participant's jaw.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oral and Maxillofacial Surgeon

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 10, 2024
• Study Start: October 1, 2024
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: July 14, 2026
• Results First Posted: July 14, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)