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

Phase 3

Completed

• Conditions: Local Anesthesia
• Interventions: Drug: sodium bicarbonate; Drug: placebo

• Registration Number: NCT02226913
• Lead Sponsor: Masoud Saatchi

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-08-25
• Study First Posted: 2014-08-27
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
lidocaine & sodium bicarbonate	sodium bicarbonate	2% lidocaine with 1: 80,000 epinephrine buffered with 0.18 mL of 8.4% sodium bicarbonate
lidocaine & placebo	placebo	2% lidocaine with 1:80,000 epinephrine with 0.18 mL of sterile distilled water

Primary Outcome Measures

Name	Time	Method
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

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