NCT03206320

Completed

Topical Lidocaine for Needle Insertion and Injection Pain

New York School of Regional Anesthesia Source

Compare

Other study identifiers

Sponsor study identifier

SMBe1701

Study Type

interventional

Actual enrollment (reported)

30

Locations

1 country

Sites

1

Timeline

Study Start

December 5, 2016

Actual (reported)

Primary Completion

July 31, 2017

Actual (reported)

Study Completion

October 31, 2019

Actual (reported)

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 30 participants
Study completion date: October 31, 2019
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 5, 2016
Actual (reported)
First Submitted
June 22, 2017
Actual (reported)
First Posted
July 2, 2017
Actual (reported)
Primary Completion
July 31, 2017
Actual (reported)
Study Completion
October 31, 2019
Actual (reported)

Last Updated: May 23, 2025
Status Verified: May 2025
Last Update Submitted: May 20, 2025

Conditions

Needle Insertion and Injection Pain

Outcome Measures

Primary Outcomes (2)

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 Outcomes (2)

Fearfulness
Just before the nerve block
Overall discomfort
Immediately at the end of the block

Study Arms (3)

Control

NO INTERVENTION

Reference

ACTIVE COMPARATOR

Drug: Lidocaine Topical

New

EXPERIMENTAL

Drug: Lidocaine Topical

Interventions

Lidocaine TopicalDrug

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

NewReference

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

New York School of Regional Anesthesia
Otherlead

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, B-3600, Belgium

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Enrollment

30 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Anesthesiologist

Study Record Dates

First Submitted

June 22, 2017

First Posted

July 2, 2017

Study Start

December 5, 2016

Actual (reported)

NCT02708433

Clinical Outcomes of Buffered 1% Lidocaine vs. Non-buffered 2% Lidocaine

Not ApplicableCompleted

NCT02620501

Does Use of Topical Lidocaine in EGD Reduce Amount of IV Midazolam and Fentanyl Required and Shorten Recovery Time

Not ApplicableUnknown

NCT03620591

Lidocaine and Analgesia After Laparoscopic Cholecystectomy

Not ApplicableCompleted

NCT04008433

Median Effective Dose of Lidocaine for the Prevention of Pain Caused by the Injection of Propofol Formulated With Medium-/Long-chain Triglycerides

Not ApplicableCompleted

NCT03530033

Lidocaine Reduces Muscle Tremor is Beneficial for Intraoperative Recurrent Laryngeal Nerve Monitoring

Not ApplicableUnknown

NCT02257346

Intravenous Lidocaine and Quality of Recovery After Cesarean Delivery

Not ApplicableWithdrawn

ASA I-III physical class

Scheduled for elective shoulder or upper arm surgery requiring a preoperative interscalene brachial (ISBP) or axillary (AX) plexus block

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

July 31, 2017

Actual (reported)

Study Completion

October 31, 2019

Actual (reported)

Last Updated

May 23, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03206320
Data provider: ClinicalTrials.gov
Source updated: 2025-05-23
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:40:32 UTC

Locations

BE(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (3)

Control

Reference

New

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations