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临床试验/NCT07595471
NCT07595471进行中(未招募)不适用

The Impact of Injection Level on the Proximal Spread of Local Anesthetic and Clinical Outcomes in Adductor Canal Block

Ankara Etlik City Hospital1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2026年4月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
68
试验地点
1
主要终点
Proximal spread of local anesthetic

研究概览

简要总结

This prospective, randomized clinical study is designed to evaluate the effects of two different injection levels of adductor canal block (ACB) on the proximal spread of local anesthetic and clinical outcomes in patients undergoing total knee arthroplasty. The study will be conducted at Ankara Etlik City Hospital and will include a total of 68 patients. All cases are limited to unilateral elective knee replacement surgeries performed under spinal anesthesia. In this study, the comparison will be based on the application of adductor canal block at two distinct injection levels. In both groups, blocks will be performed under ultrasound (USG) guidance using the same technical principles and standardized conditions; in the first group, the block will be administered at the level where the vasto-adductor membrane is first visualized, while in the second group, it will be performed at the level where the adductor longus ends. The type, concentration, and volume of local anesthetic used in both groups will be standardized as 20 mL of 0.25% bupivacaine. The groups will be compared in terms of the proximal spread of the local anesthetic based on the injection level, the area of spread at the apex of the iliopectineal fossa, the involvement of the femoral nerve, the incidence of postoperative falls, and analgesic consumption.

详细描述

This prospective, randomized clinical trial is designed to evaluate the effects of two distinct injection levels of ultrasound-guided adductor canal block (ACB) on the proximal spread of local anesthetic and clinical outcomes in patients undergoing total knee arthroplasty (TKA). The study will be conducted at Ankara Etlik City Hospital with a total of 68 patients. All cases are limited to unilateral elective knee replacement surgeries performed under spinal anesthesia. Inclusion and Exclusion Criteria Inclusion criteria are defined as patients aged 18 years and older, with an ASA (American Society of Anesthesiologists) physical status of I-III, scheduled for elective unilateral TKA under spinal anesthesia. Exclusion criteria include patients scheduled for bilateral knee arthroplasty, known allergy to local anesthetics, chronic pain syndromes or regular opioid use, peripheral neuropathy or neurological diseases affecting femoral nerve function, coagulopathy or use of anticoagulant therapy, infection at the injection site, and patients unable to provide written informed consent. Randomization and Intervention Patients will be randomized into two groups using the sealed envelope method. In Group 1, the ACB will be performed under ultrasound (USG) guidance at the level where the vasto-adductor membrane (VAM) is first visualized. In Group 2, the block will be performed at the level where the adductor longus muscle ends. All blocks will be administered by experienced anesthesiologists using a standardized dose of 20 mL 0.25% bupivacaine. Clinicians performing the block will not be involved in the postoperative data collection process. Procedure and Monitoring All patients will undergo standard monitoring, including electrocardiography (EKG), non-invasive arterial blood pressure, and peripheral oxygen saturation (SpO_2). Following the administration of spinal anesthesia according to clinical protocols, the ACB will be performed under USG guidance based on the randomization results. Standard care will be provided throughout the surgical and anesthetic management, and perioperative data will be recorded. Outcome Measures and Evaluation Following the block, the spread of the local anesthetic will be evaluated in real-time using ultrasound. The distance between the injection point and the highest proximal point of the anesthetic spread will be measured in centimeters. Additionally, the spread area of the local anesthetic at the level of the apex of the iliopectineal fossa will be recorded using the planimetric measurement tools of the USG device. The reach of the local anesthetic to the femoral nerve will also be assessed via USG. Postoperatively, patients will follow standard clinical monitoring. Motor block will be evaluated based on the incidence of postoperative falls (yes/no). Sensory block efficacy will be assessed through total analgesic consumption recorded within the first 24 hours postoperatively. All collected data will be recorded for statistical analysis and compared based on the injection levels.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

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

入选标准

  • * Patients aged > 18 years.
  • ASA physical status classification I-III.
  • Patients scheduled for elective, unilateral total knee arthroplasty (TKA).
  • Planned administration of spinal anesthesia.
  • Ability to provide written informed consent.

排除标准

  • Scheduled for bilateral knee arthroplasty.
  • Known hypersensitivity or allergy to local anesthetics.
  • History of chronic pain syndrome or regular opioid consumption.
  • Presence of peripheral neuropathy or neurological disorders affecting the femoral nerve.
  • Coagulopathy or ongoing anticoagulant therapy.
  • Active infection at the site of injection.
  • Inability or refusal to provide written informed consent.

研究组 & 干预措施

Group 1: ACB at the proximal vasto-adductor membrane level (20 mL 0.25% bupivacaine)

Active Comparator

Group 1: Patients receiving ultrasound-guided adductor canal block with 20 mL of 0.25% bupivacaine at the level where the vasto-adductor membrane is first visualized.

干预措施: Comparison of Proximal Adductor Canal Block (Drug)

Group 2: Level of the end of the adductor longus

Active Comparator

Group 2: Patients receiving ultrasound-guided adductor canal block with 20 mL of 0.25% bupivacaine at the level where the adductor longus muscle ends.

干预措施: Comparison True Distal Adductor Canal Block. (Drug)

结局指标

主要结局

Proximal spread of local anesthetic

时间窗: The first postoperative hour

The primary objective of this study is to compare the proximal spread of local anesthetic following ultrasound-guided adductor canal block performed at two distinct injection levels. In the first group, the injection will be administered at the level where the vastoadductor membrane is first visualized ultrasonographically in the proximal region. In the second group, the injection will be performed at the level where the adductor magnus and sartorius muscles first intersect.In both patient groups, the area of local anesthetic spread at the apex of the iliopectineal fossa will be measured in $cm\^2$ using ultrasonography. Additionally, the distance between the needle insertion point (injection level) and the apex of the iliopectineal fossa, as well as the distance from the needle insertion point to the most proximal point where the local anesthetic is ultrasonographically visualized, will be recorded in cm.

次要结局

  • Pain Scores (Numeric Rating Scale)(post-op hours 6 and 24)
  • Assessment of Motor Block(Postoperative 24th hours)

研究者

发起方
Ankara Etlik City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Müge Çakırca

Assoc. Professor

Ankara Etlik City Hospital

研究点 (1)

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