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Lidocaine Versus Bupivacaine in Orthognathic Surgery

NCT06450028 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-30

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Mark A Green, DDS, MD · Boston Children's Hospital, Department of Plastic and Oral Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-26
Primary Completion
2025-11-30
Completion
2025-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06450028 on ClinicalTrials.gov