RECRUITING

Lidocaine Versus Bupivacaine in Orthognathic Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Lidocaine Versus Bupivacaine in Orthognathic Surgery: A Randomized Controlled Trial

Quick Facts

Study Start:2024-07-26
Study Completion:2025-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06450028

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years to 35 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Undergoing an orthognathic procedure at Boston Children's Hospital
  2. * Between the ages of 15 and 35 years old
  1. * Any patient undergoing any other procedures in addition to their orthognathic procedure during the same sedation period (extraction, bone graft, etc.).
  2. * Any patient with a history of chronic pain.
  3. * Any patient with a history of an allergic reaction to bupivacaine or lidocaine.
  4. * Any patient with known neurologic changes to the lip or chin.
  5. * Any patient not enrolled in an Enhanced Recovery After Surgery (ERAS) Protocol.
  6. * Any patient known to be pregnant or with a positive pregnancy test prior to the procedure.

Contacts and Locations

Study Contact

Michael C Britt
CONTACT
6179192279
michael.britt@childrens.harvard.edu
Katie Bridges
CONTACT
6179191495
katie.bridges@childrens.harvard.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Boston Children's Hospital

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-26
Study Completion Date2025-07-01

Study Record Updates

Study Start Date2024-07-26
Study Completion Date2025-07-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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