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Clinical Trials in China / NCT07366853
Starting soon Not applicable

Feasibility and Safety of Sciatic Nerve Paraneural Sheath Block Using a Mid-Femoral Lateral Approach

NCT07366853 · tracked via the Priya Life Science China tracker
Sponsor
General Hospital of Ningxia Medical University
Phase
Not applicable
Started
2026-01-01
Last updated
2026-01-26

Condition(s) studied

Adverse EffectFeasibility StudySafety and Effectiveness

Investigational drug(s) / intervention(s)

Ultrasound-guided lateral mid-femoral sciatic nerve blockUltrasound-guided popliteal sciatic nerve block

Ultrasound-guided lateral mid-femoral sciatic nerve block: 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

Ultrasound-guided popliteal sciatic nerve block: 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).

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Patients scheduled for elective unilateral surgery below the knee (e.g., internal fixation for ankle, metatarsal, or calcaneal fractures; hallux valgus correction; flatfoot reconstruction). 2. American Society of Anesthesiologists (ASA) physical status class I or II. 3. Aged 18 to 65 years. 4. Ability to understand the study procedure and provide written informed consent. Exclusion Criteria: 1. 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. 2. Requirement for simultaneous surgery at a site other than the unilateral lower limb below the knee. 3. Previous surgery or significant scarring in the area of the planned needle insertion for the sciatic nerve block. 4. Body mass index (BMI) \> 35 kg/m². 5. Patients receiving chronic pain therapy or with a history of opioid abuse. 6. Inability to communicate or cooperate with the study assessments (e.g., due to cognitive impairment, language barrier, or psychiatric disorder). 7. Pregnancy or lactation.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
General Hospital of Ningxia Medical University Yinchuan Ningxia

More General Hospital of Ningxia Medical University trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07366853 on ClinicalTrials.gov ↗ ← All trials in China