US-guided Sciatic Nerve Block: Evaluation of the Intraneural Ropivacaine Minimal Effective Volume (MEV90)
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|ClinicalTrials.gov Identifier: NCT02589041|
Recruitment Status : Completed
First Posted : October 28, 2015
Last Update Posted : August 14, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|US-guided Sciatic Nerve Block||Procedure: intraneural sciatic nerve injection Drug: Ropivacaine 1%||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ultrasound-guided Popliteal Sciatic Nerve Block: an Evaluation of the Intraneural|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||April 2017|
Using an Up-and-down methodology, the first patient receives 15 ml ropivacaine 1% intraneural injection. If unsuccessful, following patient will receive an increased dose of LA (2 ml). If successful, following patient will be randomized to have either the same LA dose (9 out of 10 probability) or 2 ml reduction of LA dose (1 out of 10 probability)
Procedure: intraneural 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.
Drug: Ropivacaine 1%
- Evaluation of the Intraneural Ropivacaine Minimal Effective Volume in 90% of patients (MEV90) [ Time Frame: 6 months ]
- electrophysiological assessment of neurological deficit [ Time Frame: 5 weeks ]Electromyography of sciatic nerve bilaterally. Evaluation of velocity (m/Sec), amplitude (mV) and latency (mSec) of both peroneal and tibial components
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02589041
|Istituto Ortopedico G. Pini|
|Milan, Milano, Italy, 20122|
|Principal Investigator:||Gianluca Cappelleri, MD||ASST Gaetano Pini-CTO|