WALANT Versus Local Anesthesia in Central Venous Catheter Insertion

NCT ID: NCT07299383

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-11

Study Completion Date

2024-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 As the needle tip was slowly withdrawn, local anesthesia was induced with an average of 2-10ml lidocaine (1.5-2 mg/kg) applied to the designated 3x3cm area.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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Trauma (Including Fractures) Dialysis Catheter Malnutrition Severe

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

walant cenral venous catheter local anesthesia lidocain epinephrine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Case group

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.

Group Type ACTIVE_COMPARATOR

local anesthesia with walant solution

Intervention Type 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

Intervention Type 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.

Control (Lidocaine group)

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.

Group Type ACTIVE_COMPARATOR

Local anesthesia with lidocaine

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

local anesthesia with walant solution

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

Intervention Type PROCEDURE

Local anesthesia with lidocaine

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ataturk University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

ümit arslan

PROFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

SULTAN TUNA AKGÖL GÜR, ASSOCIATE PROFESSOR

Role: PRINCIPAL_INVESTIGATOR

ATATÜRK UNİVERSİTY

MURAT MAKSUT ÇALBAY, SPECİALİST

Role: PRINCIPAL_INVESTIGATOR

ERZURUM CİTY HOSPİTAL

MUHAMMED ÇAĞRI AYKUT, MD

Role: PRINCIPAL_INVESTIGATOR

ATATÜRK UNİVERSİTY

ORHAN ENES TUNÇEZ, MD

Role: PRINCIPAL_INVESTIGATOR

AMASYA SULUOVA STATE HOSPITAL

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Atatürk University Research Hospital

Erzurum, Erzurum, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 34181608 (View on PubMed)

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.

Reference Type RESULT
PMID: 27200187 (View on PubMed)

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.

Reference Type RESULT
PMID: 34166849 (View on PubMed)

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.

Reference Type RESULT
PMID: 19871185 (View on PubMed)

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.

Reference Type RESULT
PMID: 29199999 (View on PubMed)

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.

Reference Type RESULT
PMID: 33775887 (View on PubMed)

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.

Reference Type RESULT
PMID: 32905335 (View on PubMed)

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.

Reference Type RESULT
PMID: 33834864 (View on PubMed)

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.

Reference Type RESULT
PMID: 28886668 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Study Protocol

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://atauni.edu.tr/

Ethical files and applications for the study were made through the university system.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Ayça ÇALBAY

Identifier Type: OTHER

Identifier Source: secondary_id

B.30.2.ATA.0.01.00/830

Identifier Type: -

Identifier Source: org_study_id