Efficacy of Buffered Lidocaine in Patients With Facial Swelling

Not Applicable

Completed

• Conditions: Orofacial Swelling

• Registration Number: NCT01981772
• Lead Sponsor: Ohio State University

Brief Summary

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.

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 Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-07-31
• Study First Submitted QC: 2013-11-05
• Study First Posted: 2013-11-13
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Results First Submitted: 2015-04-24
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-08
• Last Update Submitted: 2020-10-08
• Results First Posted: 2020-10-12
• Last Update Posted: 2020-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale	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 Outcome Measures

Name	Time	Method
Postoperative Satisfaction on a 100 mm Visual Analog Scale	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.

Trial Locations

Locations (1)

The Ohio State University College of Dentistry; 🇺🇸 Columbus, Ohio, United States