The Anesthetic Efficacy of 3% Mepivacaine Plus 2% Lidocaine With 1:100,000 Epinephrine for Lower Jaw Dental Injections

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Nusstein, Ohio State University
ClinicalTrials.gov Identifier:
NCT01574807
First received: April 2, 2012
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Pain
Drug: 3% mepivacaine/2% lidocaine with 1:100,000 epinephrine combo
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-blind Study of the Anesthetic Efficacy of 3% Mepivacaine Plus 2% Lidocaine With 1:100,000 Epinephrine for Inferior Alveolar Nerve Blocks.

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Pulpal anesthesia [ Time Frame: 60 minutes per injection sequence. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Pain of injection [ Time Frame: Initial 3 minutes of study. ] [ Designated as safety issue: No ]
    A Heft-Parker Visual Analog Scale (VAS) will be used by subjects to rate the pain of injections received at three distinct times - during needle insertion, placement of the needle to target site, and deposition of the anesthetic solution at the target site. This will occur at each appointment during the anesthetic injection phase of treatment (first 3 minutes).


Enrollment: 100
Study Start Date: May 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pulpal anesthesia Drug: 3% mepivacaine/2% lidocaine with 1:100,000 epinephrine combo
1.8 mL of 3% mepivacaine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine compared to 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.

Detailed Description:

One hundred adult male and female subjects will randomly receive two sets of inferior alveolar block injections (shots) consisting of an injection of 1.8 mL of 3% mepivacaine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine, and 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 pain of the IAN block injections will also be recorded. The data will be statistically analyzed.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574807

Locations
United States, Ohio
The Ohio State University College of Dentistry, Postle Hall
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: John Nusstein, DDS, MS Chair, Division of Endodontics
  More Information

Publications:
Responsible Party: John Nusstein, Associate Professor and Chair, Divison of Endodontics, Ohio State University
ClinicalTrials.gov Identifier: NCT01574807     History of Changes
Other Study ID Numbers: Endo-Lam2012
Study First Received: April 2, 2012
Last Updated: July 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
mepivacaine
lidocaine
inferior alveolar nerve block
pulpal anesthesia
pain of injection
mepivacaine/lidocaine
lidocaine/lidocaine

Additional relevant MeSH terms:
Anesthetics
Epinephrine
Epinephryl borate
Lidocaine
Mepivacaine
Racepinephrine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Anesthetics, Local
Anti-Arrhythmia Agents
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Mydriatics
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Sodium Channel Blockers
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014