Popliteal Sciatic Nerve Block: Intraneural or Extraneural?
|Hallux Valgus||Procedure: Intraneural injection Procedure: Extraneural injection Drug: Ropivacaine Device: PAJUNK SonoPlex 22G needle.||Phase 4|
|Study Design:||Allocation: Randomized
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|
- 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.
|Study Start Date:||November 2013|
|Study Completion Date:||February 2015|
|Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01987128
|Istituto Ortopedico G. Pini|
|Milan, Milano, Italy, 20122|
|Principal Investigator:||Gianluca Cappelleri, MD||ASST Gaetano Pini-CTO|