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Completed

NCT Number: NCT06450028

Lidocaine Versus Bupivacaine in Orthognathic Surgery

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.

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Key information

Age range

15 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Bupivacaine

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.

Other names: Lidocaine

Primary outcomes

  1. Patient-Reported Pain

    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.

Secondary outcomes

  1. 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.

    Participants will be asked to whether or not they are numb on each side of their mandible/maxilla.

  2. 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.

    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.

  3. 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.

    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).

  4. 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.

    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.

  5. 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.

    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.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

Lidocaine Versus Bupivacaine in Orthognathic Surgery: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2024
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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