CompletedNot Applicable

Topical Lidocaine for Needle Insertion and Injection Pain

Belgium30 participantsStarted 2016-12-05

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Needle insertion pain

Timeframe: Immediately at the time the needle is inserted through the skin

Injection pain

Timeframe: Immediately at the end of the block

Trial details

NCT IDNCT03206320

SponsorNew York School of Regional Anesthesia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-07-31