E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Rhizarthrosis |
Rizartrosis |
|
E.1.1.1 | Medical condition in easily understood language |
arthrosis at the base of the thumb |
artrosis en la base del pulgar |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
- 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 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
a) Hombres o mujeres mayores de 18 años. b) Cirugía ambulatoria de rizartrosis. c) Aceptación libre de participar en el estudio, con consentimiento informado firmado por el paciente, tutor o familiar responsable. |
|
E.4 | Principal 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. |
a) Pacientes < 18 años. b) Que el paciente no acepte participar en el estudio. c) Alergia a los anestésicos locales /AINES d) Dolor crónico en tratamiento. e) Enfermedades neurológicas. f) CI anestesia loco-regional. |
|
E.5 End points |
E.5.1 | 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. |
La variable principal a evaluar será el DOLOR medido mediante la escala analógica analógica visual del dolor, (VAS). Se determinará el VAS máximo y el VAS a las 24 y 48 horas del postoperatorio. Además recogeremos la hora en que aparece el dolor, pudiendo calcular secundariamente el período libre de dolor desde el alta a domicilio. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | 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 |
? VAS al momento de recibir la llamada. ? VAS máximo. ? Hora de inicio de dolor desde el alta hospitalaria. ? Omisión de dosis de enantyum. ? Necesidad de analgesia de rescate, y dosis total utilizada. ? Presencia de náuseas o vómitos y medicamento utilizado para el control de éstos. ? Presencia de bloqueo motor y hora de reversión. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Evaluación ciega por terceros |
Blind evaluation by others persones |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Tratamiento convencional vs. Tratamiento convencional + intervención |
Conventional treatment Versus Conventional treatment + intervention |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The last patient finishes the study within 2 days after his/her inclusion |
El último paciente finaliza el estudio al cabo de 2 días tras su inclusión. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |