A Phase 4 interventional study of Intraneural injection and Extraneural injection in Hallux Valgus, sponsored by ASST Gaetano Pini-CTO. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-27.
Sponsored by ASST Gaetano Pini-CTO · Phase 4, Interventional, and Treatment
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.
149 studies on the registry are indexed under Hallux Valgus; 31 are open to participants now.
This study's enrollment of 88 is above the median of 60 across 111 interventional studies indexed under Hallux Valgus.
Browse Hallux Valgus studies →ASST Gaetano Pini-CTO is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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 · Drug: Ropivacaine · Device: PAJUNK SonoPlex 22G needle.
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 · Drug: Ropivacaine · Device: PAJUNK SonoPlex 22G needle.
BBraun Ropivacaine 1% 12ml injection divided in each sciatic components under echographic guidance with a PAJUNK SonoPlex 22G needle.
BBraun Ropivacaine 1% 12ml extraneural injection around sciatic nerve under echographic guidance with a PAJUNK SonoPlex 22G needle.
onset time
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.
Time frame: every 2 minutes for a maximum of 30 minutes
success rate in each group
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
Time frame: at 30 minutes
Nerve injuries
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.
Time frame: 1, 5 weeks and at 6 months after surgery
The record gives a start of Nov 2013, a primary completion of Feb 2015 and a completion of Feb 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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ASST Gaetano Pini-CTO