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Completed

NCT Number: NCT07299383

WALANT Versus Local Anesthesia in Central Venous Catheter Insertion

The goal of this clinical trial is to find out whether WALANT is an alternative local anesthesia method that can increase patient comfort and reduce pain during CVC procedure, which is one of the invasive procedures to be performed especially in areas where bleeding control is difficult.

The main questions it aims to answer are:

* Can we offer an alternative local anesthesia method that can be used to treat patients who require CVC insertion with minimum pain and maximum comfort? * Can the WALANT technique reduce the risk of complications during CVC insertion?

Participants were:

randomized using a single-blind allocation method based on hospital file numbers: odd numbers received WALANT and even numbers received lidocaine. The WALANT solution was prepared according to the standard protocol and injected into a 3×3 cm target area 20 minutes before catheter insertion. CVCs were placed without ultrasound guidance in jugular, subclavian, or femoral veins by anatomical localization. Pain intensity was assessed using the Visual Analog Scale (VAS) before and after the procedure. In the control group, after marking the anatomical location, the vein where the procedure would be performed was identified by using a 10cc syringe, which was then passed through the skin and subcutaneous tissues using negative pressure. As the needle tip was slowly withdrawn, local anesthesia was induced with an average of 2-10ml lidocaine (1.5-2 mg/kg) applied to the designated 3x3cm area. The CVC was then placed according to routine procedures. Patient assessments were recorded using a visual analog scale before and after the procedure.

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Key information

Conditions

Trauma (Including Fractures) Dialysis Catheter Malnutrition Severe Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atatürk University Research Hospital

Erzurum, 25240, Turkey (Türkiye)

About this study

Patients were included in the study if they were older than 18 years, non-pregnant, had a Glasgow Coma Scale score of 15, were oriented and cooperative, and had a hemorrhagic shock stage of at most 1 or were not in hemorrhagic shock. Patients were excluded if they were younger than 18 years, pregnant, had a Glasgow Coma Scale score of <15, were unoriented and cooperative, were in hemorrhagic shock stage >1, had coagulopathy, increased intracranial pressure, target vessel hemorrhage, obstruction, or thrombus, skin infection in the relevant area, or had burns. Sixty-four patients were included in the study between the targeted dates. Patient epidemiological characteristics, the vessel from which CVC was administered, pre- and post-treatment VAS scores, chronic diseases, medications, and any complications were recorded in the prepared case forms.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who are over 18 years of age, not pregnant, have a Glasgow Coma Scale score of 15, are oriented and cooperative, and have a hemorrhagic shock stage of at most 1 or are not in hemorrhagic shock.

Exclusion criteria

  • Patients who are younger than 18 years of age, pregnant, have <15 points on the Glasgow Coma Scale, are not oriented or cooperative, are in hemorrhagic shock stage >1, have coagulopathy, increased intracranial pressure, bleeding-obstruction-thrombus in the target vessel, skin infection in the relevant area, or have burns.

Treatment and study plan

local anesthesia with walant solution

Procedure

Walant solution was prepared using 5 ml lidocaine, 4 ml 0.9% isotonic, 1 ml 8.5% sodium bicarbonate, 1 ml 1/1000 epinephrine and an average of 2-10 ml of WALANT solution was injected into a 3x3 cm area

Local anesthesia with lidocaine

Procedure

ocal anesthesia was induced by applying an average of 2-10ml lidocaine (1.5-2 mg/kg) to the designated 3x3cm area. CVC insertion was then performed according to routine procedures.

Primary outcomes

  1. Comparison of the pain felt by patients after central venous catheter placement when local anesthesia is performed with Lidocaine and when it is performed with the Wide Awake Tourniquet-Free Local Anesthesia Technique (WALANT).

    Time frame: 45 minutes for each patient.

    To measure pain, participants were asked to describe the pain felt before and after central venous catheter insertion using a VISUAL ANALOG SCALE (VAS). They were asked to give a score of 10 for the highest pain felt and 0 for the situation where they felt no pain.

  2. Comparison of Pain Experienced by Patients After Central Venous Catheter Insertion Procedure with Local Anesthesia with Lidocaine and the Wide-Awake Tourniquet-Free Local Anesthesia Technique (WALANT)

    Time frame: The time from the beginning of the CVC insertion process until the patient can describe the pain he/she feels is a maximum of 30 minutes. The study duration was 45 minutes per patient.

    To measure pain, patients were asked to describe the pain felt before and after central venous catheter insertion using a VISUAL ANALOG SCALE (VAS). They were asked to give a score of 10 for the highest pain experienced and 0 for no pain at all. A Visual Analogue Scale (VAS) is one of the pain rating scales used for the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. From the patient's perspective, this spectrum appears continuous; their pain does not take discrete jumps, as a categorization of none, mild, moderate and severe would suggest.

  3. Pain felt after local anesthesia

    Time frame: The maximum time elapsed from the moment the patient was able to describe the pain felt after the local anesthesia procedure was 30 minutes.

    To measure pain, patients were asked to describe the pain felt before and after central venous catheter insertion using a VISUAL ANALOGUE SCALE (VAS). They were asked to give a score of 10 for the highest pain experienced and 0 for no pain at all.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

Comparison of Local Anesthesia With the Fully Awake Tourniquet-Free Local Anesthesia Technique (WALANT) in Central Venous Catheter Insertion Procedure

Acronym: WALANT

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Dec 23, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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