Efficacy of Buffered Lidocaine in Patients With Facial Swelling

October 8, 2020 updated by: Melissa Drum, Ohio State University

Anesthetic Efficacy of 4% Buffered Lidocaine in Emergency Patients With Facial Swelling.

The purpose of this study is to determine the clinical efficacy of a buffered 4% lidocaine solution for incision and drainage. Ninety patients will be examined clinically to determine a diagnosis of cellulitis or fluctuance. The diagnosis will be confirmed by incision and drainage. Patients will receive either 3.6 ml 4% lidocaine with 1:100,000 epinephrine or 3.6 ml 4% lidocaine with 1:100,000 epinephrine buffered with 8.4% sodium bicarbonate. Patients will rate pain prior to and throughout the procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Incision and drainage of swellings is painful and anesthetic failure is common. One reason may be related to the lowered pH of inflamed tissue reducing the amount of the base form of anesthetic. A buffered anesthetic solution may result in more effective anesthesia than a non-buffered solution.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University College of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years or older
  • in good health (ASA classification I or II)
  • able to give informed consent
  • necrotic tooth with associated facial swelling

Exclusion Criteria:

  • allergies to local anesthetics or sulfites
  • history of significant medical problems (ASA classification III or greater)
  • pregnancy
  • inability to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: buffered lidocaine
administration of 4% buffered lidocaine with 1:100,000 epinephrine
Drug: 4% buffered lidocaine with 1:100,000 epinephrine
see arm/group description
ACTIVE_COMPARATOR: nonbuffered lidocaine
administration of 4% lidocaine with 1:100,000 epinephrine
Drug: 4% lidocaine with 1:100,000 epinephrine
see arm/group description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale
Time Frame: during incision/drainage on Day 0
Patients will rate pain on a Heft-Parker visual analog scale during needle insertion, placement, and solution deposition phases of the anesthetic injection(s). Patients will also rate pain during the incision and dissection phases of the incision and drainage procedure. The number of millimeters along the scale are reported. No pain corresponded to 0 mm. Mild pain was defined as greater than 0 mm and less than or equal to 54 mm. Mild pain included the descriptors of "faint", "weak", and "mild pain". Moderate pain was defined as greater than 54 mm and less than 114 mm and included the descriptor "moderate". Severe pain was defined as equal to or greater than 114 mm up to and including 170 mm. Severe pain included the descriptors of "strong", "intense", and "maximum possible."
during incision/drainage on Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Satisfaction on a 100 mm Visual Analog Scale
Time Frame: immediately post-procedure on Day 0
Patients will rate their level of satisfaction with the incision and drainage procedure using a visual analog scale. The scale ranges from "not satisfied," to "somewhat satisfied," to "moderately satisfied," to "completely satisfied." Not satisfied corresponded to 0 mm. Somewhat satisfied was defined as greater than 0 mm and less than or equal to 33 mm. Moderately satisfied was defined as greater than 33 mm and less than 66 mm. Completely satisfied was defined as equal to or greater than 66 mm. Measurements along the scale were collected and analyzed by randomization test.
immediately post-procedure on Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Investigators

  • Principal Investigator: Melissa Drum, DDS, MS, The Ohio State University College of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

July 31, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (ESTIMATE)

November 13, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 12, 2020

Last Update Submitted That Met QC Criteria

October 8, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012H0437

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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