Topical Lidocaine for Needle Insertion and Injection Pain

Topical Lidocaine 2% Gel for Analgesia and Patient Comfort During Interscalene Brachial Plexus and Axillary Blocks: A Noninferiority Randomized Trial

Skin infiltration with local anesthetic is commonly used to decrease patient discomfort during peripheral nerve blocks. Topically applied local anesthetic gel might provide analgesia while eliminating the need for additional injections. The primary objective of this study was a noninferiority comparison between the analgesia achieved with topical gel with that of skin infiltration for pain upon needle insertion and injection during administration of the interscalene brachial (ISBP) and axillary (AX) plexus blocks.

Study Overview

• Status: Completed
• Conditions: Needle Insertion and Injection Pain
• Intervention / Treatment: Drug: Lidocaine Topical

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Genk, Belgium, B-3600
    • Ziekenhuis Oost-Limburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ability to understand Dutch, French or English language, purpose and risks of the study, provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations
• Age >18 at the time of informed consent
• ASA I-III physical class
• Scheduled for elective shoulder or upper arm surgery requiring a preoperative interscalene brachial (ISBP) or axillary (AX) plexus block

Exclusion Criteria:

• History of an allergy or contra-indication to a local anesthetic
• Baseline neurological deficit
• Medical condition that will make it difficult to assess sensory distribution or communicate with a staff member
• Presence of preexisting coagulation disorders
• Infection at injection site
• Concomitant opioid therapy
• Recent history (<3 months) of drug or alcohol abuse
• Female subjects who are pregnant or currently breastfeeding, or who have a positive pregnancy test result at first visit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Active Comparator: Reference	Drug: Lidocaine Topical; Comparison of lidocaine topical gel with lidocaine infiltration and with no local anesthesia in reducing needle insertion and injection pain
Experimental: New	Drug: Lidocaine Topical; Comparison of lidocaine topical gel with lidocaine infiltration and with no local anesthesia in reducing needle insertion and injection pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Needle insertion pain	Pain rating (VAS)	Immediately at the time the needle is inserted through the skin
Injection pain	Pain rating (VAS)	Immediately at the end of the block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fearfulness	Likert scale from "1" (no fear) to "5" (very fearful)	Just before the nerve block
Overall discomfort	Verbal rating scale from "0" (more comfortable/less painful than expected) to "10" (less comfortable/more painful than expected)	Immediately at the end of the block

Collaborators and Investigators

• Sponsor: New York School of Regional Anesthesia

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2016
• Primary Completion (Actual): July 31, 2017
• Study Completion (Actual): October 31, 2019

Study Registration Dates

• First Submitted: June 22, 2017
• First Submitted That Met QC Criteria: June 30, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Lidocaine
• Other Study ID Numbers: SMBe1701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No