Popliteal Sciatic Nerve Block: Intraneural or Extraneural?
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|ClinicalTrials.gov Identifier: NCT01987128|
Recruitment Status : Completed
First Posted : November 19, 2013
Last Update Posted : February 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hallux Valgus||Procedure: Intraneural injection Procedure: Extraneural injection Drug: Ropivacaine Device: PAJUNK SonoPlex 22G needle.||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
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.
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.
Device: PAJUNK SonoPlex 22G needle.
- 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.
- 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.
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
|Istituto Ortopedico G. Pini|
|Milan, Milano, Italy, 20122|
|Principal Investigator:||Gianluca Cappelleri, MD||ASST Gaetano Pini-CTO|