E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The analgesic efficacy of erector spinae plane block in lumbar spine surgery. Infiltration of local anesthetic in this plane may lower postoperative pain. |
La eficacia analgésica del bloqueo del plano del erector espinal en cirugía de columna lumbar. El uso de anestésicos locales en este plano podría ayudar a disminuir el dolor postoperatorio. |
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E.1.1.1 | Medical condition in easily understood language |
Postoperative pain after spine surgery |
Dolor postoperatorio tras cirugía de columna 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.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To campare 24h morphine consumption between patients that received erector spinae plane block and patients that did not receive any regional technique. |
Comparar el consumo de morfina durante las 24 primeras horas del postoperatorio de cirugía de columna, entre pacientes que recibieron el bloqueo del plano del erector espinal y aquellos que no recibieron ninguna técnica regional. |
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E.2.2 | Secondary objectives of the trial |
To compare between the groups: - Morphine consumption throughout hospital stay - VAS scores - Time to first mobilisation - Time to firt sitting - Time to first standing - Hospital stay |
Entre los objetivos secundarios se encuentran determinar el consumo de morfina durante todo el período de ingreso postoperatorio, la intensidad del dolor postoperatorio mediante una escala visual analógica (EVA), el tiempo transcurrido desde la cirugía hasta primera movilización, sedestación y bipedestación, y el tiempo de estancia hospitalaria postoperatoria |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients older than 18 years - American society Status classification (ASA) I-III - Elective spine surgery up to 4 spaces. - Primary surgery and reinterventions |
1) Pacientes mayores de 18 años 2) Pacientes con clasificación ASA I-III 3) Cirugía electiva de columna lumbar entre 1 y 4 espacios 4) Cirugías primarias y reintervenciones. |
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E.4 | Principal exclusion criteria |
- Urgent surgery - Infection in site of surgery - Allergy to local anesthetics, opioids u other analgesics used in the trial. - Contraindications for regional technique - Patient refusal - Absence of informed consent - Surgical complication that may interfer with adequate pain assessment |
1) Cirugía urgente; 2) Pacientes con proceso infeccioso en la zona quirúrgica; 3) Alergia a anestésicos locales, opioides u otros fármacos utilizados en el estudio; 4) presencia de contraindicaciones para la realización de anestesia regional; 5) rechazo del paciente a participar en el estudio 6) ausencia de consentimiento informado; y 7) complicación quirúrgica en el postoperatorio inmediato que impidan una adecuada valoración del paciente (ej. hemorragia con necesidad de reintervención, delirium, dolor en dermatomas relacionados con malposición de elementos quirúrgicos, etc.). |
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E.5 End points |
E.5.1 | Primary end point(s) |
First 24h morphine consumption |
Consumo de morfina durate las primeras 24h del postoperatorio |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
24h |
A las 24 horas del postoperatorio |
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E.5.2 | Secondary end point(s) |
To compare between the groups: - Morphine consumption throughout hospital stay - VAS scores - Time to first mobilisation - Time to firt sitting - Time to first standing - Hospital stay |
Comparar entre los grupos: - Consumo de morfina durante el ingreso hospitalario - EVA al ingreso, 30 min, 2, 6,24 y 48 h. - Tiempo hasta primera movilización, sedestación y bipedestación (según día de ingreso) - Estancia hospitalaria |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
During hospital stay |
Durante el ingreso hospitalario |
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
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 | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
No other regional technique |
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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 | 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
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |