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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraneural injection | Experimental | 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. |
|
| extraneural injection | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraneural injection | Procedure | BBraun Ropivacaine 1% 12ml injection divided in each sciatic components under echographic guidance with a PAJUNK SonoPlex 22G needle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | every 2 minutes for a maximum of 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 30 minutes |
| Nerve injuries |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gianluca Cappelleri, MD | ASST Gaetano Pini-CTO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico G. Pini | Milan | Milano | 20122 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27281720 | Derived | 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. |
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| ID | Term |
|---|---|
| D006215 | Hallux Valgus |
| ID | Term |
|---|---|
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D009339 | Needles |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Extraneural injection | Procedure | BBraun Ropivacaine 1% 12ml extraneural injection around sciatic nerve under echographic guidance with a PAJUNK SonoPlex 22G needle. |
|
| Ropivacaine | Drug |
|
| PAJUNK SonoPlex 22G needle. | Device |
|
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.
| 1, 5 weeks and at 6 months after surgery |
| D000588 |
| Amines |
| D004864 | Equipment and Supplies |