Effect of Sodium Bicarbonate Buffered Lidocaine on the Success of IAN Block of Teeth With Irreversible Pulpitis

Study Overview
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Brief Summary
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Buffering of local anesthetics (alkalinization) has been suggested in achieving pain control. The purpose of this prospective, randomized, double-blind study was to evaluate the effect of adding 0.6 mL 8.4% sodium bicarbonate to 3.0 mL 2% lidocaine with 1: 80,000 epinephrine on the success rate of IAN block for endodontic treatment of mandibular molars with symptomatic irreversible pulpitis.

Detailed Description
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Some studies have been shown buffering of local anesthetics reduce pain of injection, hasten the onset of anesthesia, and improved success rate of anesthesia. Others reported buffering of local anesthetics cannot reduce pain of injection, hasten the onset of anesthesia, and improve success rate of anesthesia. There are no studies evaluating a sodium bicarbonate-buffered lidocaine formulation for IAN block for teeth with irreversible pulpitis.

Official Title
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Effect of Sodium Bicarbonate Buffered Lidocaine on the Success of Inferior Alveolar Nerve Block for Teeth With Symptomatic Irreversible Pulpitis: A Prospective, Randomized Double-blind Study

Conditions
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Local Anesthesia

Intervention / Treatment
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* Drug: 2% lidocaine with 1:80,000 epinephrine
* Drug: sodium bicarbonate
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: vital mandibular molar tooth diagnosis of symptomatic irreversible pulpitis Exclusion Criteria: younger than 18 years old history of significant medical conditions allergies to local anesthetics or sulfites pregnancy taking any medications that might influence anesthetic assessment active sites of pathosis in area of injection inability to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lidocaine & sodium bicarbonate<br>2% lidocaine with 1: 80,000 epinephrine buffered with 0.18 mL of 8.4% sodium bicarbonate | Drug: 2% lidocaine with 1:80,000 epinephrine<br>* 2% lidocaine with 1:80,000 epinephrine<br>* Other names: Lignospan; Septodont, Saint Maur des Fosses, France;Drug: sodium bicarbonate<br>* 8.4% sodium bicarbonate<br>* Other names: Samen Laboratories (Mashhad, Iran);|
| Active Comparator: lidocaine & placebo<br>2% lidocaine with 1:80,000 epinephrine with 0.18 mL of sterile distilled water | Drug: 2% lidocaine with 1:80,000 epinephrine<br>* 2% lidocaine with 1:80,000 epinephrine<br>* Other names: Lignospan; Septodont, Saint Maur des Fosses, France;Drug: placebo<br>* sterile distilled water (Samen Pharmaceutical Co, Iran)<br>* Other names: sterile distilled water (Samen Pharmaceutical Co, Iran);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of the success of IAN Block anesthesia with a buffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve block |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heft-Parker visual analog scale recording of a non-buffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve block |  | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Buffered, inferior alveolar nerve block, irreversible pulpitis, local anesthesia, sodium bicarbonate