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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

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

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 weeks3 visits

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient-reported pain

Secondary study objectives

Light Touch and Directionality Perception

Numbness

Temperature Sensation

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 1Eligibility criteria met