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VENLID: The Application of a 10%-Lidocaine Spray Prior to the Insertion of a Peripheral Intra-venous Catheter in Female Adults

NCT06354816 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-02

Study results available
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Summary

Volunteers are invited to undergo 4 insertions of a peripheral intra-venous 18-gauge catheter (PIVC); 2 insertions at the the start of the study on the plantar side of the hand/vessel at the dorsum manus, 2 insertions after 2-10 hours into the forearm/cubita with and without application of a 10-% lidocaine spray (5 hubs of xylocaine 10%-pump spray; AstraZeneca BV, Zoetermeer, The Netherlands) prior to the insertion of the PIVC.

Conditions

Interventions

DRUG

Xylocaine 10% pump spray

First volunteers will undergo insertion of PIVC into the vessel of dorsum manus; 2-10 hours later: All volunteers will undergo insertion of PIVC into the forearm/cubita. Lidocaine spray 10 % serves as a local anesthesia is applied with a dispenser dispensing 0.1ml per pulse on the area of the skin, where the insertion of the PIVC is planned. Exposure time is 2 min, timed with an hour glass; validated prior to the study by a stop watch. 0.5 ml (5 pulses) of 10% lidocaine spray (equals 50mg of lidocaine) are to be applied before insertion of a PIVC 18 Gauge.

DRUG

Saline solution isotonic 0.9% NaCl

First volunteers will undergo insertion of PIVC into the vessel at dorsum manus; 2-10 hours later: All volunteers will undergo insertion of PIVC into the forearm/cubita. Physiological saline solution serves as a placebo and is applied with a dispenser dispensing 0.1ml per pulse on the area of the skin, where the insertion of the PIVC is planned. Exposure time is 2 min, timed with an hour glass; validated prior to the study by a stop watch. 0.5 ml (5 pulses) of 10% lidocaine spray (equals 50mg of lidocaine) are to be applied before insertion of a PIVC 18 Gauge.

Sponsors & Collaborators

  • Ordensklinikum Linz GmbH Krankenhaus Barmherzige Schwestern

    collaborator UNKNOWN

  • Lukas Hefler

    lead OTHER

Principal Investigators

  • Lukas Hefler, MD · Depatment of Gynekology, Ordensklinikum Linz GmbH, Barmherzige Schwestern

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-07
Primary Completion
2024-05-22
Completion
2024-05-22

Countries

  • Austria

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06354816 on ClinicalTrials.gov