Popliteal Sciatic Nerve Block: Intraneural or Extraneural?
NCT ID: NCT01987128
Last Updated: 2015-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
88 participants
INTERVENTIONAL
2013-11-30
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Intraneural injection
BBraun Ropivacaine 1% 12ml injection divided in each sciatic components under echographic guidance with a PAJUNK SonoPlex 22G needle.
Ropivacaine
PAJUNK SonoPlex 22G needle.
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.
Extraneural injection
BBraun Ropivacaine 1% 12ml extraneural injection around sciatic nerve under echographic guidance with a PAJUNK SonoPlex 22G needle.
Ropivacaine
PAJUNK SonoPlex 22G needle.
Interventions
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Intraneural injection
BBraun Ropivacaine 1% 12ml injection divided in each sciatic components under echographic guidance with a PAJUNK SonoPlex 22G needle.
Extraneural injection
BBraun Ropivacaine 1% 12ml extraneural injection around sciatic nerve under echographic guidance with a PAJUNK SonoPlex 22G needle.
Ropivacaine
PAJUNK SonoPlex 22G needle.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Diabetes
* Allergies to used drugs
* Chronic pain in treatment
* Electrophysiological alterations at time zero analysis
18 Years
ALL
No
Sponsors
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ASST Gaetano Pini-CTO
OTHER
Responsible Party
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Gianluca Cappelleri
Medical Doctor
Principal Investigators
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Gianluca Cappelleri, MD
Role: PRINCIPAL_INVESTIGATOR
ASST Gaetano Pini-CTO
Locations
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Istituto Ortopedico G. Pini
Milan, Milano, Italy
Countries
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References
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Cappelleri G, Cedrati VL, Fedele LL, Gemma M, Camici L, Loiero M, Gallazzi MB, Cornaggia G. Effects of the Intraneural and Subparaneural Ultrasound-Guided Popliteal Sciatic Nerve Block: A Prospective, Randomized, Double-Blind Clinical and Electrophysiological Comparison. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):430-7. doi: 10.1097/AAP.0000000000000413.
Other Identifiers
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IOGPGC04-13
Identifier Type: -
Identifier Source: org_study_id