Bacteriostatic Normal Saline Versus Lidocaine for Intradermal Anesthesia

NCT04495868 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STUDY00000428
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if creation of a skin wheel with bacteriostatic normal saline, which includes 0.9% benzyl alcohol, is less painful and provides a similar level of anesthesia compared to 1% lidocaine. Participants will receive both types of anesthesia, in random order.

Conditions

Chronic Pain

Keywords

Local anesthetic

Outcome Measures

Primary Outcomes (1)

• Needle Placement Pain Score

  Participants rated their pain level from the insertion of the needle for the lumbar medial branch block using the skin wheal created with each anesthetic. Pain is rated on a scale from 0 to 10, where 0 = no pain and 10 = worst pain.

  Day 1

Secondary Outcomes (1)

• Skin Wheal Pain Score

  Day 1

Study Arms (2)

Bacteriostatic Normal Saline then 1% Lidocaine

EXPERIMENTAL

Participants undergoing a lumbar medial branch block who are randomized to receive an intradermal administration of bacteriostatic normal saline followed by an intradermal administration of 1% lidocaine.

Drug: Bacteriostatic Normal Saline; Drug: 1% Lidocaine

1% Lidocaine then Bacteriostatic Normal Saline

ACTIVE COMPARATOR

Participants undergoing a lumbar medial branch block who are randomized to receive an intradermal administration of 1% lidocaine followed by an intradermal administration of bacteriostatic normal saline.

Drug: Bacteriostatic Normal Saline; Drug: 1% Lidocaine

Interventions

Bacteriostatic Normal Saline DRUG

A skin wheal will be made with bacteriostatic normal saline (BNS). BNS contains 0.9% benzyl alcohol and benzyl alcohol is an opium alkaloid that is sometimes added to physiologic normal saline for its bacteriostatic properties. The skin wheal will be created by injecting the medication intra-dermally with a 26 gauge needle.

1% Lidocaine then Bacteriostatic Normal Saline; Bacteriostatic Normal Saline then 1% Lidocaine

1% Lidocaine DRUG

A skin wheal will be made with 1% lidocaine. The skin wheal will be created by injecting the medication intra-dermally with a 26 gauge needle.

1% Lidocaine then Bacteriostatic Normal Saline; Bacteriostatic Normal Saline then 1% Lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for an initial lumbar medial branch block

You may not qualify if:

• Allergy to local anesthetics
• Fibromyalgia
• Inability to provide informed consent in English
• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Grady Pain Clinic

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Brian Bobzien, MD
• Organization: Emory University

brian.patrick.bobzien@emory.edu

404-616-4226

Study Officials

• Brian Bobzien, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 3, 2020
• Study Start: January 8, 2021
• Primary Completion: April 6, 2022
• Study Completion: April 6, 2022
• Last Updated: April 18, 2023
• Results First Posted: April 18, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available for sharing beginning immediately upon publication and ending 36 months following article publication.
• Access Criteria: Data will be available for sharing with researchers who provide a methodologically sound proposal, in order to achieve the aims in the approved proposal. Proposals should be directed to bbobzie@emory.edu. A link will be provided to the researcher for download of the data.

Locations

US (1)