Clinical Outcomes Mandible: Buffered 1% vs. Non-Buffered 1% Lidocaine

NCT ID: NCT03127943

Last Updated: 2019-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2018-04-01

Brief Summary

Assess the clinical impact of Buffered 1% lidocaine with epinephrine as compared to the Non-buffered 1% lidocaine with epinephrine in dental and oral surgical procedures.

Detailed Description

Background:

Based on the discovery of its topical and locally injected anesthetic effects at the end of the 19th century, cocaine was rapidly adopted as a means of blocking painful sensory impulses from the periphery during surgical procedures.(1) In the last decade local anesthetics have been administered more often, alone or in combination with IV or inhalation anesthetics for most surgical procedures. For clinical procedures in the head and neck the local anesthetic drugs have been combined with a vasoconstrictor, usually epinephrine, to prolong the anesthetic effect at the locally injected anatomic site. To achieve pulpal and periosteal anesthesia by nerve or field block for procedures in dentistry, lidocaine at a 2% concentration has been preferred by clinicians for its reliable outcomes. To prolong the shelf life of the vasopressor, the drug combination must be formulated with a low pH, approximately pH 3.5 for lidocaine with 1/100k epinephrine (Epi).

With a better understanding of the pharmacology, new options for improving local anesthetic effectiveness including buffering the commercially supplied drugs to a neutral pH just prior to injection, continue to emerge.(2) When injected, the low pH causes the "sting" felt by patients on injection. Buffering to a neutral pH eliminates this discomfort and makes the maximum concentration of the non-ionized form of the anesthetic drug immediately available to the targeted nerve membrane.(3-7) Until recently, buffering local anesthetics containing Epi followed with bicarbonate just prior to injection was impractical for the quantities used in intraoral procedures. However, today we do have options to efficiently accomplish this buffering technique.(Anutra Medical, Research TrianglePark, NC).

Buffering local anesthetics just prior to use produces positive outcomes including less "sting" on injection, faster onset of the drug, and possibly added drug potency, ie the same positive clinical effect at lower dosage. In pilot studies with healthy adults as their own controls investigators have shown that Buffered 1% lidocaine with 1/100k Epi was as effective as Non-buffered 2% lidocaine with 1/100k Epi for pulpal anesthesia on a 1st molar or canine after nerve block in the mandible or field block in the maxilla-Phase one of this study.(8,9) These outcomes could be beneficial for performing multiple procedures in children whose lidocaine dosage is limited by body weight or others with chronic liver disease.

Rationale:

The recently reported results from the two clinical studies involving buffered lidocaine with Epi have led to clinicians questioning whether the Buffered 1% lidocaine with Epi might be as effective for achieving pulpal and periosteal anesthesia for dental procedures as Non-Buffered 1% lidocaine with Epi-Phase two of this study, outcomes not usually considered by most clinicians. This protocol addresses that question.

Specific Aims:

Compare clinical depths of pulpal anesthesia for maxillary(Phase one) and mandibular(Phase two) molar and canine teeth at 30min intervals Post-injection of lidocaine Assess pain levels during injection Assess time after injection to lower lip numb

Hypotheses:

No differences exist in anesthetic depth for pulpal anesthesia after intraoral injection mandibular nerve block between Buffered 1% lidocaine with 1/100k epinephrine as compared to Non-buffered 1% lidocaine with 1/100k epinephrine.

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

Conditions

Anesthesia, Local

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Buffered 1% lidocaine

In week One, Each subject would be injected intraorally with either anesthetic (Buffered 1% lidocaine with 1/100,00 epinephrine) or (Non-buffered 1% lidocaine with 1/100,00 epinephrine to block the Inferior alveolar, Lingual and Buccal nerves.

At least a week later injections for the same nerves would involve the alternate anesthetic. Mandibular molar and canine tested for pulpal anesthesia.

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: DRUG

Efficacy for mandibular molar and canine anesthesia

Non-buffered 1% lidocaine

In week Two, Each subject would be injected intraorally with the alternate anesthetic (Buffered 1% lidocaine with 1/100,00 epinephrine) or (Non-buffered 1% lidocaine with 1/100,00 epinephrine to block the Inferior alveolar, Lingual and Buccal nerves.

At least a week later injections for the same nerves would involve the alternate anesthetic. Mandibular molar and canine tested for pulpal anesthesia.

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: DRUG

Efficacy for mandibular molar and canine anesthesia

Interventions

Lidocaine

Efficacy for mandibular molar and canine anesthesia

Intervention Type: DRUG

Other Intervention Names

xylocaine

Eligibility Criteria

Inclusion Criteria

Age 18-30 years American Society Anesthesiologists I,II

Exclusion Criteria

Allergy to lidocaine class of anesthetic drugs Local anesthetic drug use in past week Current symptoms in teeth or oral mucosa

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy Turvey, DDS

Role: STUDY_CHAIR

UNC Oral and Maxillofacial Surgery

Raymond P White Jr, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

UNC School of Dentistry

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

16-0068

Identifier Type: -

Identifier Source: org_study_id