Efficacy of Buffered Lidocaine in Patients With Facial Swelling

The Ohio State University

Status: Completed

Conditions: Orofacial Swelling

Treatments: Drug: 4% buffered lidocaine with 1:100,000 epinephrine; Drug: 4% lidocaine with 1:100,000 epinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT01981772

2012H0437

Details and patient eligibility

About

The purpose of this study is to determine the clinical efficacy of a buffered 4% lidocaine solution for incision and drainage. Ninety patients will be examined clinically to determine a diagnosis of cellulitis or fluctuance. The diagnosis will be confirmed by incision and drainage. Patients will receive either 3.6 ml 4% lidocaine with 1:100,000 epinephrine or 3.6 ml 4% lidocaine with 1:100,000 epinephrine buffered with 8.4% sodium bicarbonate. Patients will rate pain prior to and throughout the procedure.

Full description

Incision and drainage of swellings is painful and anesthetic failure is common. One reason may be related to the lowered pH of inflamed tissue reducing the amount of the base form of anesthetic. A buffered anesthetic solution may result in more effective anesthesia than a non-buffered solution.

Enrollment: 88 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older
• in good health (ASA classification I or II)
• able to give informed consent
• necrotic tooth with associated facial swelling

Exclusion criteria

• allergies to local anesthetics or sulfites
• history of significant medical problems (ASA classification III or greater)
• pregnancy
• inability to give informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups

buffered lidocaine

Experimental group

Description:

administration of 4% buffered lidocaine with 1:100,000 epinephrine

Treatment:

Drug: 4% buffered lidocaine with 1:100,000 epinephrine

nonbuffered lidocaine

Active Comparator group

Description:

administration of 4% lidocaine with 1:100,000 epinephrine

Treatment:

Drug: 4% lidocaine with 1:100,000 epinephrine