Optimal Lidocaine Buffering to Reduce Injection Pain in Local Anesthesia

August 16, 2023 updated by: University of Nebraska
The purpose of this study is to determine the optimal amount of lidocaine buffering needed to decrease injection pain when administering local anesthesia.

Study Overview

Status

Terminated

Conditions

Detailed Description

Once the site is chosen, the skin will be anesthetized as usual. This study will utilize a commercially prepared 1% lidocaine solution mixed with standard sodium bicarbonate. A total of 10 mL will be used.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

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

    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center

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

17 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • adults presenting for routine thyroid biopsy, paracentesis or thoracentesis in interventional radiology

Exclusion Criteria:

  • Patients requiring sedation
  • Patients with altered mental status
  • Children
  • Patients allergic to lidocaine or sodium bicarbonate

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A
10 mg/mL lidocaine; Frequency: 1
local anesthesia
Other Names:
  • xylocaine
Active Comparator: Arm B
9 mg/mL of 10% sodium bicarbonate-90% lidocaine; Frequency: 1
local anesthesia
Other Names:
  • xylocaine
additional drug added to lidocaine
Active Comparator: Arm C
7.5 mg/Ml of 25% sodium bicarbonate-75% lidocaine Frequency: 1
local anesthesia
Other Names:
  • xylocaine
additional drug added to lidocaine
Active Comparator: Arm D
5 mg/mL 50% sodium bicarbonate-50% lidocaine Frequency: 1
local anesthesia
Other Names:
  • xylocaine
additional drug added to lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Injection pain
Time Frame: 6 months
numeric pain scale
6 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Joseph McBride, MD, University of Nebraska

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.

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 (Actual)

January 8, 2016

Primary Completion (Actual)

November 5, 2021

Study Completion (Actual)

November 5, 2021

Study Registration Dates

First Submitted

December 17, 2015

First Submitted That Met QC Criteria

January 5, 2016

First Posted (Estimated)

January 6, 2016

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

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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