Skip to main content
OpenTrials
Completed

NCT Number: NCT03206320

Topical Lidocaine for Needle Insertion and Injection Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Needle Insertion and Injection Pain

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg

Genk, B-3600, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine topical

Drug

Comparison of lidocaine topical gel with lidocaine infiltration and with no local anesthesia in reducing needle insertion and injection pain

Primary outcomes

  1. Needle insertion pain

    Time frame: Immediately at the time the needle is inserted through the skin

    Pain rating (VAS)

  2. Injection pain

    Time frame: Immediately at the end of the block

    Pain rating (VAS)

Secondary outcomes

  1. Fearfulness

    Time frame: Just before the nerve block

    Likert scale from "1" (no fear) to "5" (very fearful)

  2. Overall discomfort

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

New York School of Regional Anesthesia

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Jul 2, 2017
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.