Rhizarthrosis
Conditions
Interventions
Trade Name: CHIROCANE 5mg/ml solución inyectable / concentrado para solución para perfusión
Pharmaceutical Form: Injection
INN or Proposed INN: LEVOBUPIVACAINA HIDROCLORURO
Other descriptive name: LE
Sponsors
Institut de Recerca del Hospital de la Santa Creu i Sant Pau
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Men and women over 18 years. b) Ambulatory Surgery rhizarthrosis. c) Acceptance free to participate in the study, with informed consent signed by the patient, tutor or family member. 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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: a) Patients <18 years. b) The patient does not agree to participate in the study. c) Allergy to local anesthetics / NSAIDs d) Chronic pain treatment. e) Neurological diseases f) CI local anesthesia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Estudiar la eficacia del bloqueo periférico de los nervios radial y mediano para controlar el dolor tras la cirugía ambulatoria de rizartrosis en el momento de máxima intensidad, esto es, en las primeras 24-48 horas.;Secondary Objective: - Evaluar la necesidad de medicación de rescate en ambos grupos. - Evaluar la incidencia de náuseas y vómitos, el medicamento y las dosis que de fármaco utilizadas para su tratamiento. - Adicionalmente evaluaremos la presencia de bloqueo motor y el momento de la reversión del mismo;Primary end point(s): The primary endpoint is to evaluate the pain that will be measured by visual analog scale of pain (VAS). To Determine the maximum VAS and VAS at 24 and 48 hours postoperatively. Besides, to note the time that you have pain and can calculate secondary pain-free period from discharge to home.;Timepoint(s) of evaluation of this end point: two years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? VAS at the time of the call. ? maximum VAS. ? Time to onset of pain after hospital discharge. ? Skipping doses Keral. ? Need for rescue analgesia, and total dose used. ? Presence of nausea or vomiting, and medication used to control them. ? Presence of motor block and time reversal;Timepoint(s) of evaluation of this end point: two years | — |
Countries
Spain
Contacts
Public ContactRomy Rodríguez
Institut de Recerca del Hospital de la Santa Creu i Sant Pau
Outcome results
None listed