Topical Lidocaine for Needle Insertion and Injection Pain

Not Applicable

Completed

• Conditions: Needle Insertion and Injection Pain
• Interventions: Drug: Lidocaine Topical

• Registration Number: NCT03206320
• Lead Sponsor: New York School of Regional Anesthesia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-05
• Study First Submitted: 2017-06-22
• Study First Submitted QC: 2017-06-30
• Study First Posted: 2017-07-02
• Primary Completion: 2017-07-31
• Study Completion: 2019-10-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reference	Lidocaine Topical	-
New	Lidocaine Topical	-

Primary Outcome Measures

Name	Time	Method
Needle insertion pain	Immediately at the time the needle is inserted through the skin	Pain rating (VAS)
Injection pain	Immediately at the end of the block	Pain rating (VAS)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium