E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperative pain following scoliosis surgery |
Dolor postoperatorio tras cirugía de escoliosis |
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E.1.1.1 | Medical condition in easily understood language |
Postoperative pain following scoliosis surgery |
Dolor postoperatorio tras cirugía de escoliosis |
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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 evaluate the analgesic efficacy of erector spinae plane catheters following scoliosis surgery involving more than 4 levels |
Evaluar la eficacia del uso de catéteres el plano del erector espinal en la disminución del dolor postoperatorio y del consumo de opioides en los pacientes intervenidos de cirugía de escoliosis de más de cuatro espacios. |
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E.2.2 | Secondary objectives of the trial |
To determine morphine consumption, pain scores, time to first mobilisation, sitting and standing, and hospital stay. |
Determinar el consumo de morfina durante los 3 primeros días del postoperatorio, la intensidad del dolor postoperatorio mediante una escala visual analógica (EVA) a las 0,2, 6,12,24,48 y 72h, 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 16 years old - Elective scoliosis surgery involving more than 4 spaces - ASA I-III - Primary surgery and reinterventions - Idiopathic and degenerative scoliosis |
- Pacientes mayores de 16 años - Pacientes intervenidos de forma electiva de cirugía de columna lumbar, torácica y/o toracolumbar de más de 4 espacios. - Pacientes con clasificación ASA I-III - Cirugías primarias y reintervenciones - Escoliosis idiopática y degenerativa |
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E.4 | Principal exclusion criteria |
- Urgent surgery - Infection in the site of surgery - Allergy to any of the drugs used in the study. - Patient refusal - Absence of informed consent - Surgical complication that prevents an adequate follow up (i.e. hemorrhage, delirium, etc.) |
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) |
Morphine consumption in the first 24 postoperative hours |
Determinar el consumo de morfina en las primeras 24 horas del postoperatorio. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
To determine morphine consumption during the first 3 days, pain scores (VAS) at 0,2,6,12,24,48 and 72 hours, time to first mobilisation, sitting and standing, time of hospital stay and development of surgical site infection. |
Determinar el consumo de morfina durante los 3 primeros días del postoperatorio, la intensidad del dolor postoperatorio mediante una escala visual analógica (EVA) a las 0,2, 6,12,24,48 y 72h, el tiempo transcurrido desde la cirugía hasta primera movilización, sedestación y bipedestación, el tiempo de estancia hospitalaria postoperatoria y desarrollo de infección en la zona quirúrgica. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
During hospital stay and 30 days after discharge |
Durante el ingreso hospitalario y a los 30 días del alta hospitalaria |
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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 | Yes |
E.6.13.1 | Other scope of the trial description |
Analgesic efficacy of a regional technique (erector spinae plane catheters) |
Eficacia analgésica de una técnica regional (catéteres en el plano del erector espinal) |
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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 | 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 otra técnica regional |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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
|
30 days after the last patient included in the trial is discharged from the hospital. |
A los 30 días del alta hospitalaria del último paciente incluido en el 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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |