NCT07299383

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 As the needle tip was slowly withdrawn, local anesthesia was induced with an average of 2-10ml lidocaine (1.5-2 mg/kg) applied to the designated 3x3cm area.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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 23, 2025

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

10 months

First QC Date

November 26, 2025

Last Update Submit

December 9, 2025

Conditions

Keywords

walantcenral venous catheterlocal anesthesialidocainepinephrine

Outcome Measures

Primary Outcomes (3)

  • 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.

    45 minutes for each patient.

  • 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.

    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.

  • 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.

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

Study Arms (2)

Case group

ACTIVE COMPARATOR

After 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.

Procedure: local anesthesia with walant solutionProcedure: Local anesthesia with lidocaine

Control (Lidocaine group)

ACTIVE COMPARATOR

For 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.

Procedure: Local anesthesia with lidocaine

Interventions

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

Case group

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.

Case groupControl (Lidocaine group)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk University Research Hospital

Erzurum, Erzurum, 25240, Turkey (Türkiye)

Location

Related Publications (9)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Anesthesia, LocalLidocaine

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • SULTAN TUNA AKGÖL GÜR, ASSOCIATE PROFESSOR

    ATATÜRK UNİVERSİTY

    PRINCIPAL INVESTIGATOR
  • MURAT MAKSUT ÇALBAY, SPECİALİST

    ERZURUM CİTY HOSPİTAL

    PRINCIPAL INVESTIGATOR
  • MUHAMMED ÇAĞRI AYKUT, MD

    ATATÜRK UNİVERSİTY

    PRINCIPAL INVESTIGATOR
  • ORHAN ENES TUNÇEZ, MD

    AMASYA SULUOVA STATE HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROFESSOR

Study Record Dates

First Submitted

November 26, 2025

First Posted

December 23, 2025

Study Start

January 11, 2023

Primary Completion

November 1, 2023

Study Completion

August 1, 2024

Last Updated

December 23, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
The desired data can be shared within 2 years after the study is completed and published (excluding patients' personal data).
Access Criteria
Individuals with at least a medical doctor's degree who are mentors on topics related to the study, planning a similar study design, or planning a course or academic presentation on this topic are eligible to access the data. The Correponder Author can be contacted for data sharing. Email is preferred for communication.
More information

Available IPD Datasets

Study Protocol (AYÇA ÇALBAY)Access

Locations