Hallux Valgus
Conditions
Brief summary
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.
Interventions
PROCEDUREIntraneural injection
BBraun Ropivacaine 1% 12ml injection divided in each sciatic components under echographic guidance with a PAJUNK SonoPlex 22G needle.
PROCEDUREExtraneural injection
BBraun Ropivacaine 1% 12ml extraneural injection around sciatic nerve under echographic guidance with a PAJUNK SonoPlex 22G needle.
DRUGRopivacaine
DEVICEPAJUNK SonoPlex 22G needle.
Sponsors
ASST Gaetano Pini-CTO
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ASA I-II
Exclusion criteria
* Neurological diseases * Diabetes * Allergies to used drugs * Chronic pain in treatment * Electrophysiological alterations at time zero analysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| onset time | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| success rate in each group | 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 | 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. |
Countries
Italy
Outcome results
None listed