Popliteal Sciatic Nerve Block: Intraneural or Extraneural?

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Istituto Ortopedico Gaetano Pini
Sponsor:
Information provided by (Responsible Party):
Gianluca Cappelleri, Istituto Ortopedico Gaetano Pini
ClinicalTrials.gov Identifier:
NCT01987128
First received: November 5, 2013
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

Aim of this study is to demonstrate the advantages of intraneural injection over extraneural injection in terms of onset and duration on peripheral block. In addition we will evaluate the frequency of possible adverse effects.


Condition Intervention Phase
Hallux Valgus
Procedure: Intraneural injection
Procedure: Extraneural injection
Drug: Ropivacaine
Device: PAJUNK SonoPlex 22G needle.
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Blocco Del Nervo Sciatico al Poplite, Intraneurale o Extraneurale? Confronto Prospettico, Randomizzato in Cieco Tra la modalità di Iniezione di Anestetico Locale Per il Blocco Eco Guidato Del Nervo Sciatico al Poplite Nella Chirurgia Dell'Alluce Valgo

Resource links provided by NLM:


Further study details as provided by Istituto Ortopedico Gaetano Pini:

Primary Outcome Measures:
  • onset time [ Time Frame: every 2 minutes for a maximum of 30 minutes ] [ Designated as safety issue: No ]

    Pinprick test evaluation on sciatic nerve territory:

    With a 22G needle the blinded operator will assess sensitiveness to puncture and then assign a score every 2 minutes for 30 minutes. A score of 0 will describe no sensation to puncture, on the other hand a score of 1 will be assigned if sensation to puncture is still present.

    Evaluation of motor blockade:

    Plantar and dorsal flexion of the foot will be evaluated for motor blockade of sciatic nerve. A score of 1 will be assigned if foot movement is conserved, 2 if is impaired and 3 when disappears.

    Onset time is described as the time at which pinprick score turns to 0 and motor blockade score turns to 3.



Secondary Outcome Measures:
  • success rate in each group [ Time Frame: at 30 minutes ] [ Designated as safety issue: No ]
    Success rate is described as the percentage of subjects with an onset time within 30 minutes in a group among all subjects treated in that group

  • Nerve injuries [ Time Frame: 1, 5 weeks and at 6 months after surgery ] [ Designated as safety issue: Yes ]
    Neurophysiological and clinic evaluation will be assessed either with clinical examination and electrophysiological tests by a neurophysiologist eventually evidencing any movement impairment or dysesthesia in the sciatic territory.


Estimated Enrollment: 88
Study Start Date: November 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intraneural injection
All patients in the arm will receive a single intraneural injection of 12 ml Ropivacaine 1% BBraun, Germany, in the sciatic nerve under echographic guidance.
Procedure: Intraneural injection
BBraun Ropivacaine 1% 12ml injection divided in each sciatic components under echographic guidance with a PAJUNK SonoPlex 22G needle.
Drug: Ropivacaine Device: PAJUNK SonoPlex 22G needle.
Active Comparator: extraneural injection
All patients in the arm will receive a single extraneural injection of 12 ml Ropivacaine 1% BBraun, Germany, around the sciatic nerve under echographic guidance.
Procedure: Extraneural injection
BBraun Ropivacaine 1% 12ml extraneural injection around sciatic nerve under echographic guidance with a PAJUNK SonoPlex 22G needle.
Drug: Ropivacaine Device: PAJUNK SonoPlex 22G needle.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-II

Exclusion Criteria:

  • Neurological diseases
  • Diabetes
  • Allergies to used drugs
  • Chronic pain in treatment
  • Electrophysiological alterations at time zero analysis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01987128

Contacts
Contact: Gianluca Cappelleri, MD +390258296297 gianluca.cappelleri@gpini.it

Locations
Italy
Istituto Ortopedico G. Pini Recruiting
Milan, Milano, Italy, 20122
Contact: gianluca cappelleri, MD    +390258296297    gianluca.cappelleri@gpini.it   
Principal Investigator: gianluca cappelleri, MD         
Sponsors and Collaborators
Istituto Ortopedico Gaetano Pini
Investigators
Principal Investigator: Gianluca Cappelleri, MD Istituto Ortopedico Gaetano Pini
  More Information

No publications provided

Responsible Party: Gianluca Cappelleri, Medical Doctor, Istituto Ortopedico Gaetano Pini
ClinicalTrials.gov Identifier: NCT01987128     History of Changes
Other Study ID Numbers: IOGPGC04-13
Study First Received: November 5, 2013
Last Updated: December 20, 2013
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Hallux Valgus
Foot Deformities
Musculoskeletal Diseases
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014