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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Time to Effective Block Onset Across Different Local Anesthetic Volumes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Superficial Cervical Plexus Block - 10 mL (SCPB 10 mL)
Ultrasound-guided superficial cervical plexus block administered beneath the sternocleidomastoid muscle at the C6 level using 10 mL of 1% lidocaine hydrochloride (n=25).
干预措施: Lidocaine HCl 1% (Drug)
Local Infiltration Anesthesia (LIA Group)
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).
干预措施: Lidocaine HCl 1% (Drug)
Superficial Cervical Plexus Block - 2 mL (SCPB 2 mL)
Ultrasound-guided superficial cervical plexus block administered beneath the sternocleidomastoid muscle at the C6 level using 2 mL of 1% lidocaine hydrochloride (n=25).
干预措施: Lidocaine HCl 1% (Drug)
Superficial Cervical Plexus Block - 5 mL (SCPB 5 mL)
Ultrasound-guided superficial cervical plexus block administered beneath the sternocleidomastoid muscle at the C6 level using 5 mL of 1% lidocaine hydrochloride (n=25).
干预措施: Lidocaine HCl 1% (Drug)
结局指标
主要结局
Time to Effective Block Onset Across Different Local Anesthetic Volumes
时间窗: 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).
Time to Effective Block Onset Across Different Local Anesthetic Volumes
时间窗: 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).
次要结局
- Pain Intensity Across Procedural Stages (NRS Scores)(At baseline, during infiltration/block injection, during initial needle insertion, and during catheter placement.)
研究者
AYŞENUR SELEK
MD
Kayseri City Hospital