Comparison of Local Infiltration Anesthesia and Superficial Cervical Plexus Block in Ultrasound-Guided Internal Jugular Vein Catheterization: Efficacy, Duration, and Local Anesthetic Volume - A Randomized Controlled Trial
1 other identifier
interventional
150
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedFirst Submitted
Initial submission to the registry
September 20, 2026
CompletedFirst Posted
Study publicly available on registry
September 25, 2026
CompletedSeptember 25, 2026
September 1, 2026
1 month
September 20, 2026
September 20, 2026
Conditions
Keywords
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 COMPARATOR10 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).
Superficial Cervical Plexus Block - 2 mL (SCPB 2 mL)
EXPERIMENTALUltrasound-guided superficial cervical plexus block administered beneath the sternocleidomastoid muscle at the C6 level using 2 mL of 1% lidocaine hydrochloride (n=25).
Superficial Cervical Plexus Block - 5 mL (SCPB 5 mL)
EXPERIMENTALUltrasound-guided superficial cervical plexus block administered beneath the sternocleidomastoid muscle at the C6 level using 5 mL of 1% lidocaine hydrochloride (n=25).
Superficial Cervical Plexus Block - 10 mL (SCPB 10 mL)
EXPERIMENTALUltrasound-guided superficial cervical plexus block administered beneath the sternocleidomastoid muscle at the C6 level using 10 mL of 1% lidocaine hydrochloride (n=25).
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.
Eligibility Criteria
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)
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
Condition Hierarchy (Ancestors)
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
- 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.