NCT02589041

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: ASST Gaetano Pini-CTO · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• US-guided Sciatic Nerve Block

Interventions

Type	Name	Description
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%

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-10-01
• Completion: 2017-04-01
• First posted: 2015-10-28
• Last updated: 2017-08-14

Locations

1 site across 1 country: Italy