跳至主要内容
临床试验/NCT07366853
NCT07366853尚未招募不适用

Feasibility and Safety of Intraneural Sciatic Nerve Block Via Lateral Mid-femoral Approach: A Clinical Study

General Hospital of Ningxia Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
Rate of complete sensory blockade in the sciatic nerve distribution at 30 minutes after block completion

研究概览

简要总结

This study is designed as a randomized controlled trial aiming to evaluate the feasibility and safety of ultrasound-guided mid-femoral lateral approach sciatic nerve paraneural sheath block, in order to provide a new sciatic nerve block approach for clinical practice that offers greater patient comfort and higher precision, thereby facilitating its use for specific patient populations and less experienced operators.

详细描述

In clinical practice, the popliteal approach to sciatic nerve paraneural sheath block is the most commonly used. Studies have found that compared with extraneural injection, ultrasound-guided sciatic nerve paraneural sheath block via the popliteal approach has a faster onset and provides longer postoperative sensory and motor blockade. Paraneural sheath block aims to achieve efficient, rapid, and precise nerve blockade using a low volume of local anesthetic. However, the popliteal approach requires knee flexion for performance, necessitating the patient to be in a prone or lateral decubitus position. For patients unable to flex the knee or those with positioning difficulties due to conditions such as lower limb fractures, this method is less applicable. For the above reasons, the popliteal sciatic nerve block has certain limitations.

The mid-femoral lateral approach demonstrates unique advantages: First, the patient can maintain a supine position throughout the procedure, significantly enhancing comfort and compliance. Second, the sciatic nerve is relatively superficial at this level, offering good ultrasonographic visualization and being distant from major blood vessels and nerves. This makes it applicable even in obese patients with thick subcutaneous fat and suboptimal ultrasound images, theoretically enhancing procedural safety. Therefore, it is considered an effective solution for patients with positioning restrictions, such as those with lower limb fractures and severe pain, holding high potential for clinical promotion and research significance.

Although the anatomical feasibility of this approach has been preliminarily confirmed, its practical feasibility and safety require validation through clinical studies. In particular, whether a successful "paraneural sheath block" can be consistently achieved at the mid-femoral lateral level, similar to the classic popliteal approach, remains to be explored. While some literature suggests its theoretical feasibility, there is a lack of prospective, systematic clinical research evidence to support its practical application feasibility (e.g., block efficacy, procedural difficulty, success rate) and safety (e.g., complication rates, incidence of nerve injury).

This study is designed as a randomized controlled trial aiming to evaluate the feasibility and safety of ultrasound-guided mid-femoral lateral approach sciatic nerve paraneural sheath block. The goal is to provide a new sciatic nerve block option for clinical practice that offers greater patient comfort and more precise blockade, facilitating its use for specific patient populations and less experienced operators.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for elective unilateral surgery below the knee (e.g., internal fixation for ankle, metatarsal, or calcaneal fractures; hallux valgus correction; flatfoot reconstruction).
  • American Society of Anesthesiologists (ASA) physical status class I or II.
  • Aged 18 to 65 years.
  • Ability to understand the study procedure and provide written informed consent.

排除标准

  • Contraindications to peripheral nerve block:
  • Known allergy or history of toxicity to local anesthetics.
  • Pre-existing neuropathy in the operative limb.
  • Severe coagulopathy.
  • Infection at the intended needle puncture site.
  • Systemic infection.
  • Requirement for simultaneous surgery at a site other than the unilateral lower limb below the knee.
  • Previous surgery or significant scarring in the area of the planned needle insertion for the sciatic nerve block.
  • Body mass index (BMI) > 35 kg/m².
  • Patients receiving chronic pain therapy or with a history of opioid abuse.
  • Inability to communicate or cooperate with the study assessments (e.g., due to cognitive impairment, language barrier, or psychiatric disorder).
  • Pregnancy or lactation.

研究组 & 干预措施

Lateral Mid-femoral Approach Sciatic Nerve Block

Experimental

Ultrasound-guided sciatic nerve subparaneural sheath block via the lateral mid-femoral approach. Under combined ultrasound and nerve stimulator guidance, a single injection of 20 mL of 0.5% ropivacaine hydrochloride will be administered into the paraneural sheath at the mid-femoral level.

干预措施: Ultrasound-guided lateral mid-femoral sciatic nerve block (Procedure)

Popliteal Approach Sciatic Nerve Block

Active Comparator

Ultrasound-guided sciatic nerve subparaneural sheath block via the conventional popliteal approach. Under combined ultrasound and nerve stimulator guidance, a single injection of 20 mL of 0.5% ropivacaine hydrochloride will be administered into the paraneural sheath at the popliteal fossa (prior to nerve bifurcation).

干预措施: Ultrasound-guided popliteal sciatic nerve block (Procedure)

结局指标

主要结局

Rate of complete sensory blockade in the sciatic nerve distribution at 30 minutes after block completion

时间窗: At 30 minutes after completion of the local anesthetic injection.

The proportion of patients achieving complete sensory blockade (Grade III: numbness, no sensation to pinprick) in the tibial and common peroneal nerve distributions at 30 minutes following the administration of the local anesthetic. Sensory blockade will be assessed using von Frey filaments and compared to the contralateral limb.

次要结局

  • Block Success Rate(At 30 minutes after block completion.)
  • Sensory Block Onset Time(From the end of injection until complete sensory block is achieved (assessed every 30 seconds), up to 30 minutes.)
  • Duration of Sensory Block(From block onset until first pain complaint, assessed up to 48 hours postoperatively.)
  • Motor Block Onset Time(From the end of injection until complete motor block is achieved (assessed every 30 seconds), up to 30 minutes.)
  • Duration of Motor Block(From block onset until full motor recovery, assessed up to 48 hours postoperatively.)
  • Time to First Request for Rescue Analgesia(From end of surgery until first rescue request, assessed up to 24 hours postoperatively.)
  • Total Consumption of Rescue Analgesics within 24 Hours(Within 24 hours after surgery.)
  • Postoperative Pain Intensity (NRS Scores)(At 4, 8, and 24 hours after surgery.)
  • Incidence of Rebound Pain(Within 48 hours after block resolution.)
  • Procedure-Related Times(During the block procedure.)
  • Number of Needle Redirections(During the block procedure.)
  • Incidence of Complications(From block procedure up to 1 week postoperatively.)
  • Patient Satisfaction Score(At 24 hours postoperatively.)

研究者

发起方
General Hospital of Ningxia Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验