E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pain in the lumbar arthrodesis |
Dolor en la artrodesis lumbar |
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E.1.1.1 | Medical condition in easily understood language |
Pain in the lumbar arthrodesis |
dolor en la artrodesis lumbar |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061683 |
E.1.2 | Term | Arthrodesis |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 |
The objective for this study is to evaluate the analgesic effects after administration of ketamine and intravenous dexamethasone perioperatively in patients undergoing lumbar arthrodesis and also, to study the incidence of pain and formalize perioperative analgesia. |
La necesidad de realizar este estudio es la de evaluar los efectos analgésicos tras la administración de ketamina y dexametasona vía endovenosa perioperatoriamente en pacientes sometidos a artrodesis lumbar y así mismo, estudiar la incidencia del dolor y protocolizar la analgesia perioperatoria. |
|
E.2.2 | Secondary objectives of the trial |
1 Determine the effectiveness of ketamine and intravenous dexamethasone perioperatively in patients undergoing lumbar arthrodesis. 2 Determine the incidence of pain: To study the reduction of acute postoperative pain, neuropathic pain and chronic pain in patients undergoing lumbar arthrodesis. 3. Formalize the post-operative analgesia |
1 Determinar la eficacia de la administración de ketamina y dexametasona vía endovenosa perioperatoriamente, en pacientes sometidos a artrodesis lumbar. 2 Determinar la incidencia del dolor: Estudiar la disminución del dolor agudo postoperatorio, el dolor neuropático y el dolor crónico en pacientes sometidos a artrodesis lumbar. 3. Protocolizar la analgesia post-operatoria |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
? Male or female ? Age> 18 years ? ASA I-III. ? lumbar arthrodesis. ? Patients who have signed informed consent before surgery, to participate in the study. |
? Hombre o mujer ? Edad> 18 años ? ASA I-III. ? Artrodesis lumbar. ? Pacientes que hayan firmado el consentimiento informado preoperatoriamente, para la participación en el estudio. |
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E.4 | Principal exclusion criteria |
? unstable coronary disease ? Glaucoma ? History of allergy to ketamine, morphine or dexamethasone ? Dementia or inability to understand and study the IC ? Diabetes mellitus pluricomplicada difficult to control ? Patients who have taken an experimental drug in phase 30 days before the start of the study or included in any study of an experimental drug. |
?Enfermedad coronaria inestable ?Glaucoma ?Historia de alergia a ketamina, dexametasona o cloruro mórfico ?Demencia o imposibilidad para entender el CI y el estudio ?Diabetes mellitas pluricomplicada de difícil control ?Pacientes que hayan tomado algún fármaco en fase experimental los 30 días antes del inicio del estudio o que estén incluidos en algún tipo de estudio de algún fármaco experimental. |
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E.5 End points |
E.5.1 | Primary end point(s) |
pain intensity will be assessed using the VAS questionnaire and consumption of morphine |
Se evaluará la intensidad del dolor mediante el cuestionario EVA y el consumo de cloruro mórfico |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
pain intensity will be assessed by VAS questionnaire and morphine consumption the day before surgery, the same day of surgery and 3 months after the intervention |
Se evaluará la intensidad del dolor mediante el cuestionario EVA y el consumo de cloruro mórfico el día antes de la intervención, el mismo día de la intervención y 3 meses posterior a la intervención |
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E.5.2 | Secondary end point(s) |
There are no secondary endpoints |
No se estudiaran endpoints secundarios |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Primary Endpoint will be assess once the patient completes participation in the study (3 months post intervention) |
La evaluación del endpoint se realizará una vez el paciente finalice la participación en el estudio (3 meses post intervención) |
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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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | No |
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
|
LVLS |
El estudio finalizará cuando el último paciente realice la última visita del estudio |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
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 |