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Local Anesthetic

Lidocaine vs Bupivacaine for Postoperative Pain

Phase 4
Recruiting
Led By Mark A Green, DDS, MD
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Between the ages of 15 and 35 years old
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up (1) four to six weeks prior to their orthognathic procedure, (2) approximately one hour after their orthognathic procedure, (3) approximately four hours after their orthognathic procedure, (4) one week after their orthognathic procedure.
Awards & highlights

Summary

This trial aims to compare the effects of two common local anesthetics, bupivacaine and lidocaine, on patient comfort after jaw surgery. The study will help us understand how the

Who is the study for?
This trial is for individuals aged 15-35 undergoing jaw surgery at Boston Children's Hospital. It aims to compare the effects of two local anesthetics on patient recovery.
What is being tested?
The study tests lidocaine and bupivacaine, both used in dental procedures, to see which provides better outcomes post-surgery. Patients will receive one of these drugs during their operation.
What are the potential side effects?
Possible side effects include sensitivity to touch, numbness, fever, or pain after surgery. Both anesthetics are standard care with well-known safety profiles.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 15 and 35 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~(1) four to six weeks prior to their orthognathic procedure, (2) approximately one hour after their orthognathic procedure, (3) approximately four hours after their orthognathic procedure, (4) one week after their orthognathic procedure.
This trial's timeline: 3 weeks for screening, Varies for treatment, and (1) four to six weeks prior to their orthognathic procedure, (2) approximately one hour after their orthognathic procedure, (3) approximately four hours after their orthognathic procedure, (4) one week after their orthognathic procedure. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient-reported pain
Secondary outcome measures
Light Touch and Directionality Perception
Numbness
Temperature Sensation

Trial Design

2Treatment groups
Active Control
Group I: Bupivacaine Left, Lidocaine RightActive Control2 Interventions
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.
Group II: Bupivacaine Right, Lidocaine LeftActive Control2 Interventions
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.

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Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
778 Previous Clinical Trials
5,580,912 Total Patients Enrolled
Mark A Green, DDS, MDPrincipal InvestigatorBoston Children's Hospital, Department of Plastic and Oral Surgery
~67 spots leftby May 2025
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