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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-guided lateral mid-femoral sciatic nerve block | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of complete sensory blockade in the sciatic nerve distribution at 30 minutes after block completion | 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. | At 30 minutes after completion of the local anesthetic injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Block Success Rate | Proportion of patients achieving both complete sensory blockade (Grade III) and complete motor blockade (Grade III) in the sciatic nerve distribution at 30 minutes after local anesthetic injection. | At 30 minutes after block completion. |
| Sensory Block Onset Time |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications to peripheral nerve block:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang Ma, MD,PhD | Contact | 13709519220 | magang2671@173.com | |
| Yan Ren, MD | Contact | 18152372612 | 3467592762@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Ningxia Medical University | Yinchuan | Ningxia | 750004 | China |
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This is a prospective, parallel-group, randomized, controlled, double-blinded (participant and outcome assessor), exploratory feasibility trial. It compares ultrasound-guided subparaneural sciatic nerve block via a novel lateral mid-femoral approach (experimental) with the conventional popliteal approach (active control) in patients undergoing below-knee surgery. The primary aim is to assess the feasibility and safety of the new approach. Participants are randomized 1:1. Blinding is achieved through general anesthesia (participant) and use of an independent, blinded assessor for outcome evaluation.
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| Ultrasound-guided popliteal sciatic nerve block | Procedure | 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). |
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Time interval from the end of local anesthetic injection to the achievement of complete sensory blockade (Grade III). |
| From the end of injection until complete sensory block is achieved (assessed every 30 seconds), up to 30 minutes. |
| Duration of Sensory Block | Time interval from the onset of complete sensory blockade to the first complaint of pain in the surgical area (NRS > 0). | From block onset until first pain complaint, assessed up to 48 hours postoperatively. |
| Motor Block Onset Time | Time interval from the end of local anesthetic injection to the achievement of complete motor blockade (Grade III: inability to move the ankle). | From the end of injection until complete motor block is achieved (assessed every 30 seconds), up to 30 minutes. |
| Duration of Motor Block | Time interval from the onset of complete motor blockade to the recovery of normal ankle flexion and extension. | From block onset until full motor recovery, assessed up to 48 hours postoperatively. |
| Time to First Request for Rescue Analgesia | Time interval from the end of surgery to the patient's first activation of the patient-controlled intravenous analgesia (PCIA) pump or request for supplemental analgesia. | From end of surgery until first rescue request, assessed up to 24 hours postoperatively. |
| Total Consumption of Rescue Analgesics within 24 Hours | Total dose of rescue analgesics (e.g., parecoxib, ketorolac, morphine) administered within the first 24 postoperative hours. | Within 24 hours after surgery. |
| Postoperative Pain Intensity (NRS Scores) | Pain intensity assessed using the Numerical Rating Scale (NRS, 0-10) at rest and during movement at 4, 8, and 24 hours postoperatively. | At 4, 8, and 24 hours after surgery. |
| Incidence of Rebound Pain | Proportion of patients experiencing rebound pain, defined as an NRS score >7 within 48 hours after block resolution, not relieved by multiple PCIA boluses within 30 minutes. | Within 48 hours after block resolution. |
| Procedure-Related Times |
| During the block procedure. |
| Number of Needle Redirections | Total number of times the nerve stimulation needle is adjusted or redirected to achieve the final position. | During the block procedure. |
| Incidence of Complications | Proportion of patients experiencing block-related complications, including local anesthetic systemic toxicity, nerve injury (persistent neuropathy), hematoma, or infection. | From block procedure up to 1 week postoperatively. |
| Patient Satisfaction Score | Patient-reported satisfaction with the overall anesthesia and analgesia experience, assessed using a 5-point Likert scale (0=very dissatisfied, 5=very satisfied). | At 24 hours postoperatively. |