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Topical Lidocaine for Needle Insertion and Injection Pain

N

New York School of Regional Anesthesia

Status

Completed

Conditions

Needle Insertion and Injection Pain

Treatments

Drug: Lidocaine Topical

Study type

Interventional

Funder types

Other

Identifiers

NCT03206320
SMBe1701

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

30 participants in 3 patient groups

Control
No Intervention group
Reference
Active Comparator group
Treatment:
Drug: Lidocaine Topical
New
Experimental group
Treatment:
Drug: Lidocaine Topical

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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