NCT07841782

Brief Summary

Internal jugular vein (IJV) catheterization is a common invasive procedure performed under ultrasound (USG) guidance. Providing effective analgesia during the procedure is essential for patient comfort. This prospective, randomized controlled study aims to compare the clinical efficacy, onset time, required local anesthetic volume, and hemodynamic stability between ultrasound-guided local infiltration anesthesia (LIA) and ultrasound-guided superficial cervical plexus block (SCPB) using different volumes (2 mL, 5 mL, and 10 mL of 1% lidocaine) in patients undergoing IJV catheterization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

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

June 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

1 month

First QC Date

September 20, 2026

Last Update Submit

September 20, 2026

Conditions

Keywords

central venous catheterizaton, local infiltration anesthesia, superficial cervical plexus block, lidocaine

Outcome Measures

Primary Outcomes (2)

  • Time to Effective Block Onset Across Different Local Anesthetic Volumes

    Time elapsed (in seconds) from injection completion until effective analgesia is achieved (defined as an NRS score ≤ 2 via pin-prick test every 5 seconds), evaluating whether lower volumes of SCPB (2 mL and 5 mL) achieve effective block onset in a comparable timeframe to higher volume SCPB (10 mL) and standard LIA (10 mL).

    Evaluated every 5 seconds, up to 5 minutes post-injection.

  • Time to Effective Block Onset Across Different Local Anesthetic Volumes

    Time elapsed (in seconds) from injection completion until effective analgesia is achieved (defined as an NRS score ≤ 2 via pin-prick test every 5 seconds), evaluating whether lower volumes of SCPB (2 mL and 5 mL) achieve effective block onset in a comparable timeframe to higher volume SCPB (10 mL) and standard LIA (10 mL).

    Evaluated every 5 seconds, up to 5 minutes post-injection

Secondary Outcomes (1)

  • Pain Intensity Across Procedural Stages (NRS Scores)

    At baseline, during infiltration/block injection, during initial needle insertion, and during catheter placement.

Study Arms (4)

Local Infiltration Anesthesia (LIA Group)

ACTIVE COMPARATOR

10 mL of 1% lidocaine hydrochloride is injected subcutaneously over the sternocleidomastoid muscle at the C6 level for local infiltration prior to internal jugular vein catheterization (n=75).

Drug: Lidocaine HCl 1%

Superficial Cervical Plexus Block - 2 mL (SCPB 2 mL)

EXPERIMENTAL

Ultrasound-guided superficial cervical plexus block administered beneath the sternocleidomastoid muscle at the C6 level using 2 mL of 1% lidocaine hydrochloride (n=25).

Drug: Lidocaine HCl 1%

Superficial Cervical Plexus Block - 5 mL (SCPB 5 mL)

EXPERIMENTAL

Ultrasound-guided superficial cervical plexus block administered beneath the sternocleidomastoid muscle at the C6 level using 5 mL of 1% lidocaine hydrochloride (n=25).

Drug: Lidocaine HCl 1%

Superficial Cervical Plexus Block - 10 mL (SCPB 10 mL)

EXPERIMENTAL

Ultrasound-guided superficial cervical plexus block administered beneath the sternocleidomastoid muscle at the C6 level using 10 mL of 1% lidocaine hydrochloride (n=25).

Drug: Lidocaine HCl 1%

Interventions

Administration of 1% lidocaine hydrochloride either via ultrasound-guided superficial cervical plexus block (at 2 mL, 5 mL, or 10 mL volumes) or via subcutaneous local infiltration (10 mL) prior to internal jugular vein catheterization.

Also known as: LİDON %2 (diluted %1)
Local Infiltration Anesthesia (LIA Group)Superficial Cervical Plexus Block - 10 mL (SCPB 10 mL)Superficial Cervical Plexus Block - 2 mL (SCPB 2 mL)Superficial Cervical Plexus Block - 5 mL (SCPB 5 mL)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged between 18 and 80 years
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Glasgow Coma Scale (GCS) score between 13 and 15
  • Patients scheduled for elective or semi-elective ultrasound-guided internal jugular vein catheterization
  • Patients who are literate, capable of effective communication, and provide written informed consent

You may not qualify if:

  • Glasgow Coma Scale (GCS) score \< 13
  • Age \< 18 years or \> 80 years
  • ASA physical status IV or higher
  • Internal jugular vein catheterization performed under general anesthesia
  • Internal jugular vein catheterization performed under emergency conditions
  • Distorted head and neck anatomy preventing adequate ultrasound visualization for the block
  • Arterial puncture on the first needle insertion attempt
  • Illiterate patients or patients unable to establish effective communication to evaluate pain scores
  • Known allergy or hypersensitivity to local anesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

kayseri City Hospital Department of Anesthesiology and Reanimation

Kayseri, 38080, Turkey (Türkiye)

Location

Related Publications (1)

  • Tkle HA, Pat l BM. Comparison of superfical cervical plexus block versus local infiltration for pain relief during internal jugular ven cannulation. Int J Contemp Med Res. 2018;5:I6-12.

    RESULT

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome measures (NRS pain scores and hemodynamic parameters) and block evaluations are recorded by an independent clinician who is blinded to the patient allocation and group interventions.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective, randomized, parallel-group clinical trial with four study arms. Eligible patients undergoing ultrasound-guided internal jugular vein catheterization are randomly allocated using a sealed-envelope method into either the Local Infiltration Anesthesia group (LIA, n=75) or one of the three Superficial Cervical Plexus Block volume subgroups (SCPB 2 mL, SCPB 5 mL, or SCPB 10 mL; n=25 per subgroup).
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 20, 2026

First Posted

September 25, 2026

Study Start

June 1, 2025

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

September 25, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to protect patient confidentiality and due to lack of a dedicated data repository protocol.

Locations