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

NCT06354816 | Completed Phase 4 Results DMC

• 1 other identifier: V 2.0, 07Feb2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Pain

Outcome Measures

Primary Outcomes (1)

• Pain Difference Caused by PIVC (Peripheral Intravenous Catheter) Rated by NRS (Numeric Rating Scale) Between Application of 10% Licocaine Spray and Placebo-for the Hand/Vessel at the Dorsum Manus and for the Forearm/Cubita.

  The volunteer is asked to mark her pain level in NRS (Numeric Rating Scale). NRS is a 11 point scale (0-10) where patients rate their pain intensity, with 0 being "no pain" and 10 being "the worst pain" imaginable. This tool is commonly used to measure pain severity, categorizing it as mild (1-3), moderate (4-7) or severe (8-10). To measure pain caused by PIVC (Peripheral Intravenous Catheter) rated by NRS, separately analyzed for placebo and LDA (Lidocaine 10% spray - local anesthetic) treated on the hand: vessel at the dorsum manus and forearm/cubita. In summary, this results in 4 groups (combinations of treatment-location). The NRS values reported in this outcome measure are the same as those reported in Outcome Measure 3. This outcome measure is included separately to present the pre-specified statistical comparisons of Hand - Placebo vs. Hand - LA and Forearm - Placebo vs. Forearm - LA, which differ from those presented in the companion measure.

  2 minutes

Secondary Outcomes (7)

• Pain Caused by PIVC (Peripheral Intravenous Catheter) in the Dominant Versus Non-dominant Arm.

  2 minutes

• Pain Caused by PIVC (Peripheral Intravenous Catheter) at the Hand/Vessel at the Dorsum Manus Versus at the Forearm/Cubita

  2 minutes

• Correlation Between Pain Caused by PIVC (Peripheral Intravenous Catheter) and the Anticipated Pain.

  2 minutes

• Correlation Between Pain Caused by PIVC (Peripheral Intravenous Catheter) and the Anticipated Difficulty Rated by the Operator to Insert the PIVC.

  2 minutes

• Pain Caused by PIVC (Peripheral Intravenous Catheter) Between Success and Failure of Insertion of PIVC.

  2 minutes

Study Arms (4)

A: dominant/ Saline solution isotonic 0.9% NaCl - non-dominant/Xylocaine 10% pump spray

EXPERIMENTAL

Vessel at the dorsum manus: dominant/ placebo - non-dominant/ LA (Local anaesthesia) Forearm/cubita: dominant/ placebo - non dominant/ LA (Local anaesthesia)

Drug: Xylocaine 10% pump spray; Drug: Saline solution isotonic 0.9% NaCl

B: non-dominant/ Saline solution isotonic 0.9% NaCl - dominant/ Xylocaine 10% pump spray

EXPERIMENTAL

Vessel at the dorsum manus: non-dominant/ placebo - dominant/ LA (Local anaesthesia) Forearm/cubita: non-dominant/ placebo - dominant/ LA (Local anaesthesia)

Drug: Xylocaine 10% pump spray; Drug: Saline solution isotonic 0.9% NaCl

C: non-dominant/ Xylocaine 10% pump spray - dominant/ Saline solution isotonic 0.9% NaCl

EXPERIMENTAL

Vessel at the dorsum manus: non-dominant/ LA (Local anaesthesia)- dominant/ placebo Forearm/cubita: non-dominant/ LA (Local anaesthesia) - dominant/ placebo

Drug: Xylocaine 10% pump spray; Drug: Saline solution isotonic 0.9% NaCl

D: dominant/ Xylocaine 10% pump spray - non-dominant/ Saline solution isotonic 0.9% NaCl

EXPERIMENTAL

Vessel at the dorsum manus: dominant/ LA (Local anaesthesia) - non-dominant/ placebo Forearm/cubita: dominant/ LA (Local anaesthesia) - non-dominant/ placebo

Drug: Xylocaine 10% pump spray; Drug: Saline solution isotonic 0.9% NaCl

Interventions

Xylocaine 10% pump spray DRUG

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.

Also known as: Lidocaine 10% pump spray

A: dominant/ Saline solution isotonic 0.9% NaCl - non-dominant/Xylocaine 10% pump spray; B: non-dominant/ Saline solution isotonic 0.9% NaCl - dominant/ Xylocaine 10% pump spray; C: non-dominant/ Xylocaine 10% pump spray - dominant/ Saline solution isotonic 0.9% NaCl; D: dominant/ Xylocaine 10% pump spray - non-dominant/ Saline solution isotonic 0.9% NaCl

Saline solution isotonic 0.9% NaCl DRUG

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.

Also known as: physiological Saline solution 0.9% NaCl

A: dominant/ Saline solution isotonic 0.9% NaCl - non-dominant/Xylocaine 10% pump spray; B: non-dominant/ Saline solution isotonic 0.9% NaCl - dominant/ Xylocaine 10% pump spray; C: non-dominant/ Xylocaine 10% pump spray - dominant/ Saline solution isotonic 0.9% NaCl; D: dominant/ Xylocaine 10% pump spray - non-dominant/ Saline solution isotonic 0.9% NaCl

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: female volunteers
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female probands 18-45 years
• Personal history of ever having a venipuncture or insertion of PIVC

You may not qualify if:

• Fractures on the upper extremity resulting in permanent movement restriction
• Significant burns on the upper extremity-at the discretion of the principal investgator
• Personal history of any thrombosis
• Personal history of chemotherapy
• Potential allergy to a PIVC
• Personal history of surgery in the axilla
• Personal history of any pathologies in the blood coagulation pathway
• Personal history of difficult peripheral venous access
• Personal history of complications with a PIVC
• Any concomitant use of an analgesic within the previous 24 h
• Any concomitant use of anticoagulation
• Pregnancy

Sponsors & Collaborators

• Lukas Hefler: lead
• Ordensklinikum Linz GmbH Krankenhaus Barmherzige Schwestern: collaborator

Study Sites (1)

Ordensklinikum Linz GmbH

Linz, Upper Austria, 4010, Austria

Location

MeSH Terms

Conditions

Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: VENLID
• Organization: Ordensklinikum Linz GmbH, BHS

laudia.hadjari@ordensklinikum.at

++437327677

Study Officials

• Lukas Hefler, MD

  Depatment of Gynekology, Ordensklinikum Linz GmbH, Barmherzige Schwestern

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D. Head of department of gynecology and obstetrics, MBA

Model Details: prospective, randomized, double-blind, controlled trial

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 9, 2024
• Study Start: May 7, 2024
• Primary Completion: May 22, 2024
• Study Completion: May 22, 2024
• Last Updated: April 2, 2026
• Results First Posted: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)