Topical Lidocaine for Needle Insertion and Injection Pain

NCT ID: NCT03206320

Last Updated: 2025-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-05

Study Completion Date

2019-10-31

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.

Detailed Description

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Conditions

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Needle Insertion and Injection Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Reference

Group Type ACTIVE_COMPARATOR

Lidocaine Topical

Intervention Type DRUG

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

New

Group Type EXPERIMENTAL

Lidocaine Topical

Intervention Type DRUG

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

Interventions

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Lidocaine Topical

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

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New York School of Regional Anesthesia

OTHER

Sponsor Role lead

Responsible Party

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Catherine Vandepitte, M.D.

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ziekenhuis Oost-Limburg

Genk, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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SMBe1701

Identifier Type: -

Identifier Source: org_study_id

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