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 range

18 Years – 85 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Needle Insertion and Injection Pain trials