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Popliteal Sciatic Nerve Block: Intraneural or Extraneural?

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01987128
First Posted: November 19, 2013
Last Update Posted: February 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gianluca Cappelleri, Istituto Ortopedico Gaetano Pini
  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
Intervention Model: Parallel Assignment
Masking: Double (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

Further study details as provided by Gianluca Cappelleri, Istituto Ortopedico Gaetano Pini:

Primary Outcome Measures:
  • onset time [ Time Frame: every 2 minutes for a maximum of 30 minutes ]

    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 ]
    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 ]
    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.


Enrollment: 88
Study Start Date: November 2013
Study Completion Date: February 2015
Primary Completion Date: February 2015 (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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01987128


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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gianluca Cappelleri, Medical Doctor, Istituto Ortopedico Gaetano Pini
ClinicalTrials.gov Identifier: NCT01987128     History of Changes
Other Study ID Numbers: IOGPGC04-13
First Submitted: November 5, 2013
First Posted: November 19, 2013
Last Update Posted: February 27, 2015
Last Verified: February 2015

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