E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Phantom limb pain following amputation of the lower leg due to critical limb ischemia. |
Dolor de miembro fantasma tras amputación de miembro inferior debido a isquemia crítica |
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E.1.1.1 | Medical condition in easily understood language |
Phantom limb pain following amputation of the lower leg because of vascular disease and subsequent insufficient blood flow |
Dolor de miembro fantasma tras amputación de miembro inferior debido a isquemia crítica |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004227 |
E.1.2 | Term | Below knee amputation |
E.1.2 | System Organ Class | 100000004865 |
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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 aim of this study is to test the hypothesis that a combination of optimized intravenous pain therapy and continuous sciatic nerve block decreases the point prevalence of phantom limb pain 12 months after transtibial amputation for peripheral vascular disease when compared to optimized intravenous pain therapy alone. |
Confirmar la hipótesis de que la combinación de terapia analgésica intravenosa junto a bloqueo continuo del nervio ciático disminuye la prevalencia de dolor del miembro fantasma 12 meses después de una amputación transtibial por enfermedad vascular periférica, en comparación con sólo terapia analgésica intravenosa. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are to determine the Quality of Life of patients following amputation, and the Genotype of patients . Gene haplotype will be assayed for association with acute to chronic pain conversion using single nucleotide polymorphisms (SNPs) from known risk factor genes. |
Los objetivos secundarios son: determinar la calidad de vida de los pacientes tras la amputación y el genotipo de los pacientes. Determinar el genotipo de los pacientes incluidos en el estudio, preoperatoriamente, para valorar la asociación entre algunos factores genéticos de riesgo conocidos (SNPs) y la conversión del dolor agudo a dolor crónico. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients undergoing elective transtibial amputation for peripheral vascular disease, age over 18 years, ASA* status II to IV.
*ASA American Society of Anesthesiology. |
Pacientes ´programados para cirugía electiba de amputación transtibial por enfermedad vascular periférica, edad mayor de 18 años, estado físico ASA de II-IV
ASA*Sociedad Americana de Anestesiología |
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E.4 | Principal exclusion criteria |
- contraindication to peripheral regional anesthesia
- confirmed allergy to local anesthetics
- prior amputation resulting in current phantom limb pain
- severe psychiatric disease
- pregnancy or breastfeeding status
- amputation for tumour surgery
- traumatic amputation and
- inability to give written and informed consent. |
- Contraindicación para la anestesia regional periférica.
- Alergia confirmada a anestésicos locales.
- Amputación anterior resultante en dolor del miembro fantasma en el momento del reclutamiento.
- Enfermedad psiquiátrica severa.
- Estado de gestación o lactancia.
- Amputación por causa tumoral o traumática.
- Imposibilidad de obtener el consentimiento informado por escrito.
|
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E.5 End points |
E.5.1 | Primary end point(s) |
Point prevalence of phantom limb pain 12 months postoperatively
defined as
- Pain in the amputated area of the limb with a corresponding NRS score of ? 2 during the preceding 4 weeks (constant or at least three episodes) OR
- Ingestion of drugs administered specifically to treat phantom limb pain during the preceding 4 weeks (classified as none, non-opiate, weak opiate, strong opiate, antidepressant, anticonvulsant, other). |
Prevalencia de dolor del miembro fantasma a los 12 meses postcirugía.definido como:
- Dolor en el área amputada de la extremidad con una puntuación en la NRS de ≥2
durante las 4 semanas anteriores (ya sea de forma continua o paroxístico en, al menos, tres episodios), y/o;
- Ingesta de fármacos administrados específicamente para tratar el dolor del miembro fantasma durante las 4 semanas previas (clasificados como ninguno, no-opioide, opioide débil, opioide fuerte, antidepresivo, anticonvulsivante, otro).
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 months following amputation. |
12 meses tras la amputación |
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E.5.2 | Secondary end point(s) |
- Quality of life assessed using the SF-12v2 Short form 12
- Pain characterization using the McGill short Pain Questionnaire
- Employment status (yes/no)
- Incidence of stump pain
- Vascular preoperative status
- SIGAM mobility scale
- Inventarization of rehabilitation methods applied during follow-up
- Inventarization of drugs used to treat phantom limb pain
- Incidence of reamputation and surgical complications
- Intensity of postoperative pain and phantom limb pain assessed using the NRS scale twice daily at 08:00 and 20:00 during the first 7 days postoperatively
- Overall Benefit of Analgesia Score (OBAS), determined daily at 20:00 from the day preceding surgery, until 7 days postoperatively
- Recording of surgical handling of nerves / surgical technique
- Genetic profile determined at end of study with blood drawn preoperatively |
- Calidad de vida, medida mediante el cuestionario SF-12.
- Caracterización del dolor utilizando el cuestionario de dolor McGill
- Situación laboral (activo/parado).
- Incidencia de dolor en el muñón.
- Estado vascular preoperatorio
- Escala de movilidad SIGAM
- Aplicación de métodos de rehabilitación durante el seguimiento
- Inventarización de fármacos utilizados para el tratamiento del miembro fantasma
- Incidencia de reamputación y de las complicaciones quirúrgicas
- Intensificación del dolor postoperatorio y dolor de miembro fantasma diagnosticado por usando la escala NRS dos veces diariamente a las 8 de la mañana y las 8 de la tardedurante los 7 primeros días del postoperatorio.
- Valoración de los beneficios de la escala analgésica OBAS determinada diariamente a las 8 de la tarde desde el día previo a la cirugía hasta los 7 días del postoperatorio
- Registro de las técnica quirúrgica utilizada
- Presencia o no de factores genéticos asociados al dolor crónico, determinada mediante el análisis de una muestra de sangre extraída preoperatoriamente. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Before surgery, during the first week after surgery, and after 1, 6, and 12 months. |
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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 | Yes |
E.6.3 | Therapy | No |
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 | 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 | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
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 end of the trials is defined as the last follow-up visit of the last patient one year after amputation. |
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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 | 3 |
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 | 3 |
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 |