Anesthesia
Conditions
Keywords
lidocaine, jaw
Brief summary
Anecdotal data suggest that the buffered form of the local anesthetic is more potent at equal dosages, and a lower dosage of the drug might be used with an effect equal to higher dosage not buffered. Clinical data are needed to confirm these anecdotal data. No data exist comparing buffered local anesthetics at lower drug concentrations to current dosages commonly used in dental and oral surgical procedures
Detailed description
Specific Aims: Compare clinical depths of pulpal anesthesia (cold, Electronic Pulp Test) for mandibular molar, and canine teeth at 30 minute intervals post injection for mandibular block anesthesia with buffered 1% lidocaine with 1/100,000 epinephrine as compared to non-buffered 2% lidocaine with 1/100,000 epinephrine. Hypotheses: No differences exist in anesthetic depth for pulpal anesthesia after intraoral injection for mandibular block anesthesia between buffered 1% lidocaine with 1/100,000 epinephrine as compared to non-buffered 2% lidocaine with 1/100,000 epinephrine. Study Time Frame: 6 months Month One: Recruit 24 volunteers as subjects. Prepare case-books. Months Two-Three: Clinical Study, Months Four-Five: Analyze data Month Six: Prepare Abstracts, Papers Methods: Blinded, Randomized Clinical Design Recruit subjects with Institutional Review Board approved consent at UNC Subjects will serve as their own controls in a cross-over AB/BA study design which is uniform within sequences, uniform within periods, and balanced Randomized subjects to be injected orally for mandibular block (inferior alveolar, lingual, buccal nerves) alternatively with 4cc of buffered 1% lidocaine with 1/100,000 epinephrine and 4cc non-buffered of 2% lidocaine with 1/100,000 epinephrine. Assessment: pre, and post-anesthetic administration for pulpal anesthesia with cold, Electronic Pulp Test: Mandibular molar, canine at 30 minute intervals Inclusion Criteria: Age 18-30 years, American Society Anesthesiologists (ASA) I Exclusion Criteria Allergy to lidocaine class of anesthetic drugs, Local anesthetic drug past week Current symptoms teeth or oral mucosa. SAS will be used for database management and statistical analysis.
Interventions
DRUGLidocaine
Lidocaine
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-30 years, ASA I
Exclusion criteria
* Allergy to lidocaine class of anesthetic drugs Local anesthetic drug use in past week Current symptoms teeth or oral mucosa
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Time to Pulpal Response After Mandibular Molar Anesthesia | Every 30 minutes up to 120 minutes total | Subject's Mandibular first molar teeth tested before anesthetic and every 30 minutes after for response to Cold and Electric Pulp Test as reported by subjects as a yes or no. |
| Mean Time to Pulpal Response After Mandibular Canine Anesthesia | Every 30 minutes up to 120 minutes total | Subject's Mandibular canine teeth will be tested before anesthetic and every 30 minutes after for response to Cold and Electronic Pulp Test for presence of anesthesia as reported by participants yes or no. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants who were randomized to received either Buffered 1% Lidocaine or Non-buffered 2% Lidocaine | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 23 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 0 / 23 | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 |
Outcome results
Primary
Mean Time to Pulpal Response After Mandibular Canine Anesthesia
Subject's Mandibular canine teeth will be tested before anesthetic and every 30 minutes after for response to Cold and Electronic Pulp Test for presence of anesthesia as reported by participants yes or no.
Time frame: Every 30 minutes up to 120 minutes total
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buffered 1% Lidocaine, Then Non-buffered 2% Lidocaine | Mean Time to Pulpal Response After Mandibular Canine Anesthesia | 82 Minutes | Standard Deviation 48 |
| Non-Buffered 2% Lidocaine, Then Buffered 1% Lidocaine | Mean Time to Pulpal Response After Mandibular Canine Anesthesia | 85 Minutes | Standard Deviation 48 |
p-value: 0.595% CI: [-0.89, 0.52]Wilcoxon (Mann-Whitney)
Primary
Mean Time to Pulpal Response After Mandibular Molar Anesthesia
Subject's Mandibular first molar teeth tested before anesthetic and every 30 minutes after for response to Cold and Electric Pulp Test as reported by subjects as a yes or no.
Time frame: Every 30 minutes up to 120 minutes total
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buffered 1% Lidocaine, Then Non-buffered 2% Lidocaine | Mean Time to Pulpal Response After Mandibular Molar Anesthesia | 99 Minutes | Standard Deviation 49 |
| Non-Buffered 2% Lidocaine, Then Buffered 1% Lidocaine | Mean Time to Pulpal Response After Mandibular Molar Anesthesia | 98 Minutes | Standard Deviation 45 |
p-value: 0.7495% CI: [-0.49, 0.57]Wilcoxon (Mann-Whitney)