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Completed

NCT Number: NCT01981772

Efficacy of Buffered Lidocaine in 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.

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Key information

Conditions

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University College of Dentistry

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4% lidocaine with 1:100,000 epinephrine

Drug

see arm/group description

4% buffered lidocaine with 1:100,000 epinephrine

Drug

see arm/group description

Primary outcomes

  1. 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."

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 13, 2013
Registry last updated
Oct 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.