Pain
Conditions
Keywords
mepivacaine, lidocaine, inferior alveolar nerve block, pulpal anesthesia, mepivacaine/lidocaine, lidocaine/lidocaine
Brief summary
The inferior alveolar nerve block (shot) is the most frequently used injection technique for achieving local anesthesia (numbness) for the teeth in the lower jaw. However, this injection does not always result in successful pulpal (tooth) anesthesia (patient felt pain). No study has combined mepivacaine and lidocaine anesthetics (numbing solutions) for this type of injection (shot). The investigators propose to compare an injection of mepivacaine followed by lidocaine to an injection of lidocaine followed by lidocaine to determine if there is a difference in effectiveness.
Detailed description
One hundred adult male and female subjects will randomly receive two sets of inferior alveolar block injections (shots) consisting of; 1.) an injection of 1.8 mL of 3% mepivacaine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine, and 2.) an injection of 1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine, at two separate appointments spaced at least two weeks apart, in a crossover design. Whether the subject receives the mepivacaine or the lidocaine for the first injection will be determined randomly. The doctor will not know whether the subject receives mepivacaine or lidocaine for the first injection. The subject will not know which anesthetics he/she receives. A pulp tester will be used to test the lower jaw teeth (molars, premolars, and incisors) for anesthesia (numbness) in 4-minute time cycles for 60 minutes. The data will be statistically analyzed.
Interventions
DRUGmepivacaine + lidocaine followed by lidocaine +lidocaine
1.8 mL of 3% mepivacaine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine
DRUGlidocaine + lidocaine followed by mepivacaine + lidocaine
1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 3% mepivacaine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* between the ages of 18 and 65 years * good health (ASA classification I or II) * able to provide informed consent
Exclusion criteria
* allergy to lidocaine or mepivacaine * history of significant medical problem (ASA classification III or greater) * depression * have taken CNS depressants (including alcohol or any analgesic medications) within the last 48 hours * lactating or pregnant * inability to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving Pulpal Anesthesia Success. | 60 minutes per injection sequence. | An electric pulp tester will be used to test the lower jaw teeth (molars, premolars, and incisors) for anesthesia (numbness) in 4-minute time cycles for 60 minutes. Measurements of less than 80 on the EPT is considered not numb (anesthesia failure). Readings of 80 equate to anesthetic success. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred from august 2011 to May 2013 in the dental clinic of the College of Dentistry.
Pre-assignment details
No subjects were excluded from the study.
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants receive 3% mepivacaine + 2% lidocaine versus 2% lidocaine + 2% lidocaine injections in different randomized sequences. | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 100 Participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
Number of Participants Achieving Pulpal Anesthesia Success.
An electric pulp tester will be used to test the lower jaw teeth (molars, premolars, and incisors) for anesthesia (numbness) in 4-minute time cycles for 60 minutes. Measurements of less than 80 on the EPT is considered not numb (anesthesia failure). Readings of 80 equate to anesthetic success.
Time frame: 60 minutes per injection sequence.
Population: Success of anesthesia was determined by subject achieving maximal level (80) with testing device by 5th testing time period (17 min.) following injection and maintaining that maximal response for the remainder of the testing time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mepivacaine + Lidocaine | Number of Participants Achieving Pulpal Anesthesia Success. | 44 Participants |
| Lidocaine + Lidocaine | Number of Participants Achieving Pulpal Anesthesia Success. | 40 Participants |
p-value: 1McNemar