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Clinical Trials/NCT02226913
NCT02226913
Completed
Phase 3

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

Masoud Saatchi0 sites80 target enrollmentFebruary 2013

Overview

Phase
Phase 3
Intervention
sodium bicarbonate
Conditions
Local Anesthesia
Sponsor
Masoud Saatchi
Enrollment
80
Primary Endpoint
Percentage of the success of IAN Block anesthesia with a buffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve block
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
September 2013
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Masoud Saatchi
Responsible Party
Sponsor Investigator
Principal Investigator

Masoud Saatchi

associate professor

Isfahan University of Medical Sciences

Eligibility Criteria

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

Arms & Interventions

lidocaine & sodium bicarbonate

2% lidocaine with 1: 80,000 epinephrine buffered with 0.18 mL of 8.4% sodium bicarbonate

Intervention: sodium bicarbonate

lidocaine & placebo

2% lidocaine with 1:80,000 epinephrine with 0.18 mL of sterile distilled water

Intervention: placebo

Outcomes

Primary Outcomes

Percentage of the success of IAN Block anesthesia with a buffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve block

Time Frame: Baseline

Secondary Outcomes

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

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