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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
Sponsor:
Information provided by (Responsible Party):
Gianluca Cappelleri, ASST Gaetano Pini-CTO

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.


Condition or disease Intervention/treatment Phase
US-guided Sciatic Nerve Block Procedure: intraneural sciatic nerve injection Drug: Ropivacaine 1% Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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)
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%



Primary Outcome Measures :
  1. Evaluation of the Intraneural Ropivacaine Minimal Effective Volume in 90% of patients (MEV90) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Italy
Istituto Ortopedico G. Pini
Milan, Milano, Italy, 20122
Sponsors and Collaborators
ASST Gaetano Pini-CTO
Investigators
Principal Investigator: Gianluca Cappelleri, MD ASST Gaetano Pini-CTO

Responsible Party: Gianluca Cappelleri, MD, ASST Gaetano Pini-CTO
ClinicalTrials.gov Identifier: NCT02589041     History of Changes
Other Study ID Numbers: IOGPGC10
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017

Keywords provided by Gianluca Cappelleri, ASST Gaetano Pini-CTO:
intraneural sciatic block

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents