E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ipsilateral shoulder pain after thoracotomy for lung resection. |
Dolor de hombro ispsilateral posttoracotomía para resección pulmonar |
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E.1.1.1 | Medical condition in easily understood language |
After performing thoracic surgery the patient usually presents pain in the shoulder in the same side of the surgical incision. |
Después de la cirugía torácica, el paciente suele presentar dolor en el hombro ipsilateral al hemitórax intervenido. |
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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 asses, using phrenic nerve electroneurografy, if the periphrenic fat pad infiltration with 10cc 2% lidocaine during lung resection surgery produces a functional alteration of the phrenic nerve and therefore an alteration of the ipsilateral hemidiaphragm motility. |
Evaluar mediante electroneurografía del nervio frénico, si la infiltración de lidocaína al 2% en la grasa perifrénica durante la cirugía de resección pulmonar produce una alteración funcional del nervio frénico y, en consecuencia, se reduce la motilidad del hemidiafragma ipsilateral a la cirugía. |
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E.2.2 | Secondary objectives of the trial |
1- To compare the clinical and spirometric alteration degree produced by the periphrenic fat pad infiltration with 10 cc of 2% lidocaine vs placebo in patients undergoing lung surgery.
2- To compare pain intensity in both groups |
1. Comparar el grado de afectación clínica y espirométrica generado por la infiltración con lidocaína 2% vs placebo en la grasa periférica en los pacientes intervenidos de cirugía de resección pulmonar. 2. Comparar la intensidad de dolor en ambos grupos.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-18-85 years old patients undergoing lung resection surgery using postero-lateral thoracotomy.
-Signed Informed consent of this study |
-Pacientes de 18 a 85 años sometidos a cirugía de resección pulmonar mediante incisión póstero-lateral. -El paciente deberá haber firmado un consentimiento informado específico para el presente estudio
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E.4 | Principal exclusion criteria |
-Inability or contraindication to perform epidural analgesia. -Epidural analgesia malfunction intra or post-surgery -Neuromuscular diseases, previous shoulder pain or chronic analgesic use -Lidocaine allergy -Vertebral fractures and/or high spinal cord injuries (C4 or above) -Previous diaphragm paralysis of the hemithorax undergoing surgical procedure -Inflammatory polyradiculoneuropathies or other neuromuscular diseases. -Patients with pacemaker -Morbid obesity (BMI>40) -Incapacity to understand analogical visual and or verbal pain scales -Extended lung resection including chest wall and/or vertebral bodies -Pregnancy or lactation -Patient refusal to participate |
-Imposibilidad o contraindicación de realizar la punción epidural. -Enfermedades neuromusculares, dolor de hombro previo o uso crónico de analgésicos. -Alergia a lidocaína -Fracturas vertebrales/ lesiones medulares altas (C4 y superiores). -Parálisis diafragmática ipsilateral al nervio frénicos evaluado, de cualquier etiología. -Polirradiculoneuropatías inflamatorias y otras patologías neuromusculares de base. -Portador de marcapasos. -Obesidad mórbida ( IMC>40) -Imposibilidad de comprensión de las escalas analógica visual (EVA) y/o verbal. -Resección de costillas, vértebras u otros componentes óseos de la caja torácica. (En este apartado no se incluye la realización de costotomía controlada previa al acceso a la cavidad pleural). -Embarazo o lactancia -Negativa del paciente a participar en el estudio
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety end point: median change of latency (ms) and amplitude (mV) of the registered CMAP (Compound muscle action potential) between basal measure and the one measured after surgery (4-6 hours) in both groups. (Basal measure: intraoperative just before lung resection). |
•Variable de seguridad: cambio en la mediana de la medición de la latencia (ms) y la amplitud (mV) del CMAP (Compound muscle action potential) registrado basal y después de la cirugía (aproximadamente a las 4-6 horas de la infiltración) en ambos grupos de tratamiento. La medición basal se realizará en el acto operatorio, antes de la resección pulmonar. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Four to six hours after the study drug administration |
A las 4-6 horas tras la adminsitración del fármaco en estudio. |
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E.5.2 | Secondary end point(s) |
Efficacy end point: Proportion of patients with an ipsilateral shoulder pain VAS<3 at four hours after the end of surgery in both groups
Safety end points: Median differences in CMAP´s latency and amplitude between basal measure and those measured at 1, 5 and 10 minutes after drug administration and at the end of surgery. Median differences in spirometric values (Vital forced capacity, Forced expiratory volume in 1 second and Tiffeneau Index) between pre and post-surgery (4 hours after surgery) in both groups. ?Proportion of patients with radiological ipsilateral hemidiaphragm elevation in both groups (within first 12 postoperative hours) ?Proportion of patients with pneumonia, atelectasis and/or mechanical ventilation (invasive or non-invasive) within the first 72 postoperative hours. |
Variable de eficacia: •Porcentaje de pacientes sin dolor de hombro del lado de la cirugía a las 4 horas tras la cirugía (EVA<3) en ambos grupos de tratamiento. Variables de seguridad: •Evolución de las medianas de las mediciones de latencia y amplitud del CMAP hasta las 4-6 horas tras la infiltración (1, 5, 10 minutos tras la infiltración y al finalizar la cirugía). •Cambios de los valores espirométricos medidos con la Capacidad vital forzada (FVC), el Volumen espiratorio forzado (FEV1) y el Indice de Tiffeneau (IT) pre y post-operatorios (4 horas) en ambos grupos. •Porcentaje de pacientes con presencia de elevación del hemidiafragma del lado de la cirugía en ambos grupos valorada por radiografía. •Porcentaje de pacientes con neumonía, atelectasia y/o necesidad de ventilación mecánica (invasiva no invasiva) durante el postoperatorio inmediato (primeras 72 horas postquirúrgicas).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Efficacy end point: at four hours after the end of surgery in both groups
Safety end points: Median differences in CMAP´s latency and amplitude between basal measure and those measured at 1, 5 and 10 minutes after drug administration and at the end of surgery. Median differences in spirometric values (Vital forced capacity, Forced expiratory volume in 1 second and Tiffeneau Index) between pre and post-surgery (4 hours after surgery) in both groups. ?Proportion of patients with radiological ipsilateral hemidiaphragm elevation in both groups (within first 12 postoperative hours) ?Proportion of patients with pneumonia, atelectasis and/or mechanical ventilation (invasive or non-invasive) within the first 72 postoperative hours. |
Variable de eficacia: a las 4 horas del final de la cirugía en ambos grupos.
Variable de seguridad: •Evolución de las medianas de las mediciones de latencia y amplitud del CMAP hasta las 4-6 horas tras la infiltración (1, 5, 10 minutos tras la infiltración y al finalizar la cirugía). •Cambios de los valores espirométricos medidos con la Capacidad vital forzada (FVC), el Volumen espiratorio forzado (FEV1) y el Indice de Tiffeneau (IT) pre y post-operatorios (4 horas) en ambos grupos. •Porcentaje de pacientes con elevación del hemidiafragma del lado de la cirugía en ambos grupos. •Porcentaje de pacientes con neumonía, atelectasia y/o necesidad de ventilación mecánica (invasiva no invasiva) durante el postoperatorio inmediato (primeras 72 horas postquirúrgicas).
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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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | 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 | 18 |
E.8.9.1 | In the Member State concerned days | |