Clinical Trials Directory

Trials / Completed

CompletedNCT07299383

WALANT Versus Local Anesthesia in Central Venous Catheter Insertion

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
64 (actual)
Sponsor
Ataturk University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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 As the needle tip was slowly withdrawn, local anesthesia was induced with an average of 2-10ml lidocaine (1.5-2 mg/kg) applied to the designated 3x3cm area.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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDURElocal anesthesia with walant solutionWalant 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
PROCEDURELocal anesthesia with lidocaineocal 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.

Timeline

Start date
2023-01-11
Primary completion
2023-11-01
Completion
2024-08-01
First posted
2025-12-23
Last updated
2025-12-23

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07299383. Inclusion in this directory is not an endorsement.