Efficacy of Buffered Lidocaine in Patients With Facial Swelling

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

Official Title
-----------------
Anesthetic Efficacy of 4% Buffered Lidocaine in Emergency Patients With Facial Swelling.

Conditions
-----------------
Orofacial Swelling

Intervention / Treatment
-----------------
* Drug: 4% lidocaine with 1:100,000 epinephrine
* Drug: 4% buffered lidocaine with 1:100,000 epinephrine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: buffered lidocaine<br>administration of 4% buffered lidocaine with 1:100,000 epinephrine | Drug: 4% buffered lidocaine with 1:100,000 epinephrine<br>* see arm/group description<br>|
| Active Comparator: nonbuffered lidocaine<br>administration of 4% lidocaine with 1:100,000 epinephrine | Drug: 4% lidocaine with 1:100,000 epinephrine<br>* see arm/group description<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale | Patients will rate pain on a Heft-Parker visual analog scale during needle insertion, placement, and solution deposition phases of the anesthetic injection(s). Patients will also rate pain during the incision and dissection phases of the incision and drainage procedure. The number of millimeters along the scale are reported. No pain corresponded to 0 mm. Mild pain was defined as greater than 0 mm and less than or equal to 54 mm. Mild pain included the descriptors of faint, weak, and mild pain. Moderate pain was defined as greater than 54 mm and less than 114 mm and included the descriptor moderate. Severe pain was defined as equal to or greater than 114 mm up to and including 170 mm. Severe pain included the descriptors of strong, intense, and maximum possible. | during incision/drainage on Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Satisfaction on a 100 mm Visual Analog Scale | Patients will rate their level of satisfaction with the incision and drainage procedure using a visual analog scale. The scale ranges from not satisfied, to somewhat satisfied, to moderately satisfied, to completely satisfied. Not satisfied corresponded to 0 mm. Somewhat satisfied was defined as greater than 0 mm and less than or equal to 33 mm. Moderately satisfied was defined as greater than 33 mm and less than 66 mm. Completely satisfied was defined as equal to or greater than 66 mm. Measurements along the scale were collected and analyzed by randomization test. | immediately post-procedure on Day 0 |