Hallux valgus correction MedDRA version: 16.1 Level: LLT Classification code 10011123 Term: Correction Hallux Valgus System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Magnesio Solfato S.A.L.F. 1g/10ml
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: Saline solution 0.9%
Product Name: 0,9% sodio cloruro
Product Code: 030902023
Pha
Sponsors
Università Campus Bio-Medico di Roma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient undergoing Hallux valgus surgery Age >18 years ASA I-III Informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Local infection at the site of the block Allergy to local anestethic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of efficacy of Magnesium as local anesthetic adjuvant;Secondary Objective: not applicable;Primary end point(s): Evaluation of efficacy of Magnesium as local anesthetic adjuvant;Timepoint(s) of evaluation of this end point: Intraoperative: 5 min, 10min, 15 min, 20min. Valuation of block onset Postoperative: 3 h, 6h, 12h, 24h. Valuation of block offset | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): valuation of analgesic needs;Timepoint(s) of evaluation of this end point: Postoperative: 3 h, 6h, 12h, 24h. | — |
Countries
Italy
Contacts
Public ContactAnestesia
Università Campus Bio-Medico di Roma
Outcome results
None listed