Reducing Pain of Lidocaine Injection

Does Sodium Bicarbonate Reduce the Pain of Lidocaine for Local Anesthesia in Percutaneous Breast Biopsies?

The purpose of this study is to determine the benefit, if any, of buffering lidocaine (adding sodium bicarbonate) when used for local anesthesia prior to percutaneous breast needle core biopsies. The medicine doctors use to reduce the pain of breast biopsies, lidocaine, can cause pain for approximately 15 seconds until the numbing effect begins. It is possible that this pain is caused because lidocaine is acidic. Some physicians believe that reducing the acidity of lidocaine by mixing it with sodium bicarbonate will reduce the initial pain of injecting the lidocaine. Both approaches - injecting 1% lidocaine alone and injecting 1% lidocaine mixed with sodium bicarbonate - are used as routine standard of care by radiologists today. The purpose of this study is to determine if either approach is more comfortable for patients having breast procedures.

Study Overview

• Status: Completed
• Conditions: Pain of Anesthesia at Breast Biopsy
• Intervention / Treatment: Drug: 1% Lidocaine; Drug: 1% Lidocaine plus sodium bicarbonate

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 21 Years of age
• Any patient scheduled for a breast biopsy at Duke Breast Interventional Imaging

Exclusion Criteria:

• Less than 21 Years of age
• Allergic to Lidocaine or Sodium Bicarbonate
• Not mentally capable of consenting

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1% Lidocaine; 1% Lidocaine alone.	Drug: 1% Lidocaine
Active Comparator: 1% Lidocaine plus sodium bicarbonate; 1% Lidocaine plus 8.4% sodium bicarbonate	Drug: 1% Lidocaine plus sodium bicarbonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.	immediately prior to anesthetizing, within approximately 1 minute of starting

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.	immediately on completion of anesthetizing the skin, within approximately 1 minute of starting
Pain	Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.	immediately on completion of anesthetizing the parenchyma (deeper breast tissue), within approximately 4 minutes of starting
Pain	Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.	immediately on completion of the biopsy, within approximately 20 minutes of starting
Pain	Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.	30 seconds after initiating superficial injection in the subcutaneous tissue, within approximately 1 minute of starting
Pain	Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.	immediately prior to injection of "deep" anesthesia in the breast parenchyma, within approximately 4 minutes of starting
Pain	Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.	30 seconds after initiating deep injection of the parenchyma (deeper breast tissue), within approximately 4 minutes of starting
Pain	Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.	immediately prior to obtaining the first core biopsy specimen, within approximately 15 minutes of starting
Pain	Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.	immediately after obtaining the first core biopsy specimen, within approximately 15 minutes of starting
Pain	Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.	immediately on completion of the final core biopsy specimen, within approximately 20 minutes of starting

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Jay A Baker, MD, Duke Health

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: October 13, 2014
• First Submitted That Met QC Criteria: November 7, 2014
• First Posted (Estimate): November 11, 2014

Study Record Updates

• Last Update Posted (Estimate): April 15, 2016
• Last Update Submitted That Met QC Criteria: March 16, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: Pro00056728