Catheterization, Central Venous, Pain, Procedural, Internal Jugular Vein Cannulation
Conditions
Keywords
internal jugular venous catheterization, local infiltration anesthesia, superficial cervical plexus block, central venous catheterization
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.
Detailed description
Central venous catheterization (CVC) is a widely used invasive procedure in critically ill and high-risk surgical patients for fluid resuscitation, hemodynamic monitoring, continuous infusion of vasoactive or venosclerotic drugs, and hemodialysis/hemofiltration. Among available vascular access sites, internal jugular vein (IJV) cannulation is the most commonly preferred route. However, awake patients undergoing IJV catheterization often experience significant pain and distress, which may negatively impact hemodynamic stability, patient comfort, and procedural success. Although local infiltration anesthesia (LIA) is traditionally used to provide analgesia during IJV catheterization, it frequently falls short of providing optimal pain control. Ultrasound-guided regional anesthesia techniques, such as superficial cervical plexus block (SCPB), have emerged as effective alternatives for procedures involving the anterolateral neck region. While both LIA and SCPB are utilized in clinical practice, there is a lack of prospective randomized literature directly comparing different local anesthetic volumes, onset times, and overall clinical efficacy between these two approaches. This prospective, randomized controlled trial aims to evaluate and compare ultrasound-guided LIA and SCPB in terms of anesthetic efficacy, onset time, required local anesthetic volume, and hemodynamic stability in patients undergoing IJV catheterization.
Interventions
DRUGLidocaine HCl 1%
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.
Sponsors
Kayseri City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome measures (Numeric Ratio Scale (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.
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Effective Block Onset Across Different Local Anesthetic Volumes | Evaluated every 5 seconds, up to 5 minutes post-injection. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Across Procedural Stages (NRS Scores) | At baseline, during infiltration/block injection, during initial needle insertion, and during catheter placement. | Evaluation of pain intensity using the Numerical Rating Scale (NRS, 0 = no pain to 10 = worst pain) to compare whether low-volume SCPB provides comparable pain control to high-volume SCPB and LIA across different procedural steps. |
Countries
Turkey (Türkiye)
Outcome results
None listed