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

NCT ID: NCT02589041

Last Updated: 2017-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-04-30

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.

Conditions

US-guided Sciatic Nerve Block

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intraneural

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)

Group Type: EXPERIMENTAL

intraneural sciatic nerve injection

Intervention Type: PROCEDURE

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.

Ropivacaine 1%

Intervention Type: DRUG

Interventions

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.

Intervention Type: PROCEDURE

Ropivacaine 1%

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ASST Gaetano Pini-CTO

OTHER

Sponsor Role: lead

Responsible Party

Gianluca Cappelleri

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gianluca Cappelleri, MD

Role: PRINCIPAL_INVESTIGATOR

ASST Gaetano Pini-CTO

Locations

Istituto Ortopedico G. Pini

Milan, Milano, Italy

Countries

Italy

Other Identifiers

IOGPGC10

Identifier Type: -

Identifier Source: org_study_id