Topical Lidocaine for Needle Insertion and Injection Pain

Study Overview
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Brief Summary
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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.

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

Conditions
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Needle Insertion and Injection Pain

Intervention / Treatment
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* Drug: Lidocaine Topical


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 |