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

US-guided Sciatic Nerve Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02589041
• Other study ID #: IOGPGC10
• Status: Completed
• Phase: N/A
• First received: October 22, 2015
• Last updated: August 11, 2017
• Start date: November 2015
• Est. completion date: April 2017

Study information

• Verified date: August 2017
• Source: ASST Gaetano Pini-CTO
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• US-guided Sciatic Nerve Block

Intervention

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%

Locations

Country	Name	City	State
Italy	Istituto Ortopedico G. Pini	Milan	Milano

Sponsors (1)

Lead Sponsor	Collaborator
ASST Gaetano Pini-CTO

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the Intraneural Ropivacaine Minimal Effective Volume in 90% of patients (MEV90)		6 months
Secondary	electrophysiological assessment of neurological deficit	Electromyography of sciatic nerve bilaterally. Evaluation of velocity (m/Sec), amplitude (mV) and latency (mSec) of both peroneal and tibial components	5 weeks