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

Local Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02226913
• Other study ID #: 193396
• Status: Completed
• Phase: Phase 3
• First received: July 2, 2014
• Last updated: August 29, 2016
• Start date: February 2013
• Est. completion date: September 2013

Study information

• Verified date: August 2016
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Local Anesthesia
• Pulpitis

Intervention

Drug:
• 2% lidocaine with 1:80,000 epinephrine
2% lidocaine with 1:80,000 epinephrine
• sodium bicarbonate
8.4% sodium bicarbonate
• placebo
sterile distilled water (Samen Pharmaceutical Co, Iran)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Masoud Saatchi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Heft-Parker visual analog scale recording of a non-buffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve block		Baseline	Yes