Comparing lidocaine and bupivacaine for pain management in jaw surgery
Lidocaine Versus Bupivacaine in Orthognathic Surgery: A Randomized Controlled Trial
This study is testing whether lidocaine or bupivacaine works better for managing pain and improving recovery in young people having jaw surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 15 Years to 35 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06450028 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of two local anesthetics, lidocaine and bupivacaine, on patient outcomes following orthognathic surgery. It will assess patient-reported experiences related to pain, numbness, temperature sensation, and touch perception after the administration of these anesthetics. The research will involve patients aged 15 to 35 undergoing jaw surgery at Boston Children's Hospital, comparing the efficacy and side effects of both anesthetics. The goal is to enhance postoperative recovery and patient satisfaction by understanding how anesthetic choice impacts their experience.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 15 to 35 who are scheduled for orthognathic procedures at Boston Children's Hospital.
Not a fit: Patients undergoing additional procedures during the same sedation period or those with chronic pain or allergies to the anesthetics will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing orthognathic surgery.
How similar studies have performed: Previous studies have shown varying outcomes with different local anesthetics in surgical settings, making this approach both relevant and necessary for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Mark A Green, DDS, MD — Boston Children's Hospital, Department of Plastic and Oral Surgery
- Study coordinator: Michael C Britt
- Email: michael.britt@childrens.harvard.edu
- Phone: 6179192279
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.