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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGeneral Hospital of Ningxia Medical University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultrasound-guided lateral mid-femoral sciatic nerve block

    Procedure/Surgery

    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

    Procedure/Surgery

    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).

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Lateral Mid-femoral Approach Sciatic Nerve BlockExperimental treatment 1 intervention
Group B: Popliteal Approach Sciatic Nerve BlockActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At 30 minutes after completion of the local anesthetic injection.

Secondary outcomes

1

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.

Time frame
At 30 minutes after block completion.
2

Sensory Block Onset Time

Time interval from the end of local anesthetic injection to the achievement of complete sensory blockade (Grade III).

Time frame
From the end of injection until complete sensory block is achieved (assessed every 30 seconds), up to 30 minutes.
3

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).

Time frame
From block onset until first pain complaint, assessed up to 48 hours postoperatively.
4

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).

Time frame
From the end of injection until complete motor block is achieved (assessed every 30 seconds), up to 30 minutes.

Other outcomes

Sponsors and contacts

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