Topical Lidocaine for Needle Insertion and Injection Pain

N/ACompletedNCT03206320

New York School of Regional Anesthesia30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Needle Insertion and Injection Pain

Interventions

Lidocaine TopicalDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Ziekenhuis Oost-Limburg

Genk, Belgium

Outcomes

Primary Outcomes

Needle insertion pain

Pain rating (VAS)

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

Injection pain

Pain rating (VAS)

Time frame: Immediately at the end of the block

Secondary Outcomes

Fearfulness

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

Time frame: 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)

Time frame: Immediately at the end of the block

Data from ClinicalTrials.gov

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