Orofacial Swelling
Conditions
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.
Interventions
DRUG4% lidocaine with 1:100,000 epinephrine
see arm/group description
DRUG4% buffered lidocaine with 1:100,000 epinephrine
see arm/group description
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale | during incision/drainage on Day 0 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Satisfaction on a 100 mm Visual Analog Scale | immediately post-procedure on Day 0 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Buffered Lidocaine administration of 4% buffered lidocaine with 1:100,000 epinephrine
4% buffered lidocaine with 1:100,000 epinephrine | 45 |
| Nonbuffered Lidocaine administration of 4% lidocaine with 1:100,000 epinephrine
4% lidocaine with 1:100,000 epinephrine | 43 |
| Total | 88 |
Baseline characteristics
| Characteristic | Nonbuffered Lidocaine | Buffered Lidocaine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants | 45 Participants | 88 Participants |
| Age, Continuous | 36.3 years STANDARD_DEVIATION 13.4 | 36.8 years STANDARD_DEVIATION 13 | 36.55 years STANDARD_DEVIATION 13.2 |
| Region of Enrollment United States | 43 participants | 45 participants | 88 participants |
| Sex: Female, Male Female | 19 Participants | 19 Participants | 38 Participants |
| Sex: Female, Male Male | 24 Participants | 26 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 43 |
| other Total, other adverse events | 0 / 45 | 0 / 43 |
| serious Total, serious adverse events | 0 / 45 | 0 / 43 |
Outcome results
Primary
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.
Time frame: during incision/drainage on Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buffered Lidocaine | Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale | 69.3 units on a scale | Standard Deviation 60.1 |
| Nonbuffered Lidocaine | Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale | 59.2 units on a scale | Standard Deviation 50.5 |
Secondary
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.
Time frame: immediately post-procedure on Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buffered Lidocaine | Postoperative Satisfaction on a 100 mm Visual Analog Scale | 92.7 units on a scale | Standard Deviation 15.1 |
| Nonbuffered Lidocaine | Postoperative Satisfaction on a 100 mm Visual Analog Scale | 89.5 units on a scale | Standard Deviation 13.7 |