Skip to content

US-guided Sciatic Nerve Block: Evaluation of the Intraneural Ropivacaine Minimal Effective Volume (MEV90)

Ultrasound-guided Popliteal Sciatic Nerve Block: an Evaluation of the Intraneural

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02589041
Enrollment
45
Registered
2015-10-28
Start date
2015-11-30
Completion date
2017-04-30
Last updated
2017-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

US-guided Sciatic Nerve Block

Keywords

intraneural sciatic block

Brief summary

This prospective, double-blinded study evaluates intraneural ropivacaine 1% Minimal Effective Volume (MEV90) for ultrasound-guided (US) popliteal sciatic nerve block, with Up-and-down methodology. To evaluate any neurological complications, an electrophysiological assessment will also be performed preoperatively and at 5 weeks after surgery.

Detailed description

At least 45 patients undergoing hallux valgus repair will be enrolled. A baseline bilateral sciatic nerve electrophysiological study will be performed preoperatively. Patients will be placed in prone position and a high-frequency (8-12 MHz) linear array transducer (Snerve, Sonosite, USA) will be used to identify the sciatic nerve in a transverse cross-sectional view at the apex of the popliteal fossa. As the best view of the sciatic nerve with its paraneural and neural sheath, just proximal to the point of bifurcation, will be obtained, the nerve dimension (medial-lateral and cranio-caudal diameters) will be determined and registered. An 80 mm 22-gauge needle (Sonoplex, Pajunk, Germany) will be inserted using the US-guided in-plane technique under the epineurium. The positioning will be evaluated injecting 1 ml of sodium-chloride 0.9% solution and observing the nerve swelling, if correct the local anaesthetic (LA) solution will be injected. The first patient will receive 15 ml of ropivacaine 1% (150 mg). Following patients will receive LA volume based on Up-and-down methodology. Clinical follow-up will be performed at 12, 24, 48 hours, 1 and 5 weeks and 6 months after surgery. At 5 weeks electrophysiological study will also be performed in all patients and repeated at 6 months in case of positive findings.

Interventions

PROCEDUREintraneural sciatic nerve injection

A popliteal intraneural sciatic nerve block will be performed under ultrasound guidance. Minimal effective volume will be evaluated performing a randomization based on the Up-and-down methodology. A baseline and postoperative electrophysiological study will assess the presence of any neurological complication.

Sponsors

ASST Gaetano Pini-CTO
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age above 18 years old * ASA I-III * Signed informed consensus

Exclusion criteria

* ASA IV * Unstable neurological disease * DM type I-II * Allergy to ropivacaine-mepivacaine * Opioid chronic treatment * Consensus refusal or not valid * Rheumatoid arthritis * Baseline electrophysiological study positive finding * Postoperative intensive care required

Design outcomes

Primary

MeasureTime frame
Evaluation of the Intraneural Ropivacaine Minimal Effective Volume in 90% of patients (MEV90)6 months

Secondary

MeasureTime frameDescription
electrophysiological assessment of neurological deficit5 weeksElectromyography of sciatic nerve bilaterally. Evaluation of velocity (m/Sec), amplitude (mV) and latency (mSec) of both peroneal and tibial components

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026