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Trauma (Including Fractures)WALANTNCT07299383

WALANT Versus Local Anesthesia in Central Venous Catheter Insertion

A study testing local anesthesia with walant solution and Local anesthesia with lidocaine in people with Trauma (Including Fractures) and Dialysis Catheter, run by Ataturk University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
local anesthesia with walant solution and Local anesthesia with lidocaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteTurkey (Türkiye)
Study dates
11 Jan 2023to 1 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Atatürk University Research Hospital

    Erzurum, Erzurum, 25240

Other trials in Turkey (Türkiye)

About this study

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

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:

Read more
  • 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.

Read the 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.

Being tested
local anesthesia with walant solution, Local anesthesia with lidocaine
Keywords
walant, cenral venous catheter, local anesthesia, lidocain, epinephrine
Medical subject headings
Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • local anesthesia with walant solutionProcedure or surgery

    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 lidocaineProcedure or surgery

    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.

Study groups in NCT07299383
Study groupRoleWhat they receive
Case groupActive comparatorAfter selecting the area where the CVC would be inserted (femoral vein, subclavian vein, jugular vein), anatomical localization was determined without using any guide such as USG, and the vein where the procedure would be performed was determined by using a 10cc syringe with negative pressure and passing through the skin and subcutaneous tissues. An average of 2-10ml of WALANT solution was injected into the designated 3x3cm area while the needle tip was slowly withdrawn. After waiting 20 minutes, CVC placement was performed. Patient assessments were recorded using a visual analog scale before and at the end of the procedure.
Receives: Procedure: local anesthesia with walant solution; Procedure: Local anesthesia with lidocaine
Control (Lidocaine group)Active comparatorFor the control group, patients requiring a CVC were selected as single-blind and underwent the procedure in the emergency resuscitation room. After selecting the catheter insertion site after marking the anatomical location, the vein to be treated was identified by using a 10cc syringe and applying negative pressure to the skin and subcutaneous tissues. While the needle was slowly withdrawn, local 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. Patient assessments were recorded before and after the procedure using a VAS.
Receives: Procedure: Local anesthesia with lidocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    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.

    Measured: 45 minutes for each patient.

  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)

    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.

    Measured: 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.

  3. Pain felt after local anesthesia

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2025
  2. Study start11 Jan 2023
  3. Primary completion1 Nov 2023
  4. Study completion1 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07299383
Sponsor's protocol ID
B.30.2.ATA.0.01.00/830
Other IDs
Ayça ÇALBAY
Acronym
WALANT
Status last verified
Dec 2025
First submitted
26 Nov 2025
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Epidemiological data in the case form prepared for the study, chronic disease/chronic medication use, VAS values of the study, and data on the presence of complications can be shared.

Publications

  • Arik HO, Coskun T, Kose O. Management of spaghetti wrist under WALANT technique. Hand Surg Rehabil. 2021 Oct;40(5):655-659. doi: 10.1016/j.hansur.2021.06.006. Epub 2021 Jun 21.

    PubMed 34166849
  • Abell RG, Page IH. THE REACTION OF PERIPHERAL BLOOD VESSELS TO ANGIOTONIN, RENIN, AND OTHER PRESSOR AGENTS. J Exp Med. 1942 Mar 1;75(3):305-14. doi: 10.1084/jem.75.3.305.

    PubMed 19871185
  • Yayla EM, Ozdemir L. Effect of Inhalation Aromatherapy on Procedural Pain and Anxiety After Needle Insertion Into an Implantable Central Venous Port Catheter: A Quasi-Randomized Controlled Pilot Study. Cancer Nurs. 2019 Jan/Feb;42(1):35-41. doi: 10.1097/NCC.0000000000000551.

    PubMed 29199999
  • Samantaray A, Hanumantha Rao M, Sahu CR. Additional Analgesia for Central Venous Catheter Insertion: A Placebo Controlled Randomized Trial of Dexmedetomidine and Fentanyl. Crit Care Res Pract. 2016;2016:9062658. doi: 10.1155/2016/9062658. Epub 2016 Apr 21.

    PubMed 27200187
  • Dar QA, Avoricani A, Rompala A, Levy KH, Shah NV, Choueka D, White CM, Koehler SM. WALANT Hand Surgery Does Not Require Postoperative Opioid Pain Management. Plast Reconstr Surg. 2021 Jul 1;148(1):121-130. doi: 10.1097/PRS.0000000000008053.

    PubMed 34181608
  • Moscato L, Laborde A, Kouyoumdjian P, Coulomb R, Mares O. Trapeziometacarpal (TMC) arthroplasty under Wide Awake Local Anesthesia with No Tourniquet (WALANT) versus Local Anesthesia with peripheral nerve blocks (LAPNV): Perioperative pain and early functional results in 30 patients. Hand Surg Rehabil. 2021 Sep;40(4):453-457. doi: 10.1016/j.hansur.2021.03.006. Epub 2021 Mar 26.

    PubMed 33775887
  • Tahir M, Chaudhry EA, Zaffar Z, Anwar K, Mamoon MAH, Ahmad M, Jamali AR, Mehboob G. Fixation of distal radius fractures using wide-awake local anaesthesia with no tourniquet (WALANT) technique: A randomized control trial of a cost-effective and resource-friendly procedure. Bone Joint Res. 2020 Jul 1;9(7):429-439. doi: 10.1302/2046-3758.97.BJR-2019-0315.R1. eCollection 2020 Jul.

    PubMed 32905335
  • Wellington I, Cusano A, Ferreira JV, Parrino A. WALANT Technique versus Sedation for Endoscopic Carpal Tunnel Release. Hand (N Y). 2023 Mar;18(2):214-221. doi: 10.1177/15589447211003180. Epub 2021 Apr 9.

    PubMed 33834864
  • Lalonde DH. Conceptual origins, current practice, and views of wide awake hand surgery. J Hand Surg Eur Vol. 2017 Nov;42(9):886-895. doi: 10.1177/1753193417728427. Epub 2017 Sep 8.

    PubMed 28886668

Questions about this trial

What is this clinical trial studying?

A study testing local anesthesia with walant solution and Local anesthesia with lidocaine in people with Trauma (Including Fractures) and Dialysis Catheter, run by Ataturk University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07299383, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.

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