Topical Lidocaine for Needle Insertion and Injection Pain

NCT03206320 | Completed

• 1 other identifier: SMBe1701
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Needle Insertion and Injection Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Fearfulness

  Just before the nerve block

• Overall discomfort

  Immediately at the end of the block

Study Arms (3)

Control

NO INTERVENTION

Reference

ACTIVE COMPARATOR

Drug: Lidocaine Topical

New

EXPERIMENTAL

Drug: Lidocaine Topical

Interventions

Lidocaine Topical DRUG

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

New; Reference

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York School of Regional Anesthesia: lead

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, B-3600, Belgium

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: July 2, 2017
• Study Start: December 5, 2016
• Primary Completion: July 31, 2017
• Study Completion: October 31, 2019
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)