E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The combined use with local anesthetics may allow for a reduction in the dose of the latter, without impairment of intraoperatory anesthesia, improving the early mobility of patients and minimizing the adverse effects. |
El uso combinado en la misma solución de opioides y anestésicos locales utilizados en la raquianestesia podría permitir una reducción en la dosis de éstos últimos sin menoscabo de la eficacia anestésica intraoperatoria, disminuir los efectos adversos de los anestésicos, especialmente la movilidad de las extremidades, y mantener un efecto analgésico en el postoperatorio. |
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E.1.1.1 | Medical condition in easily understood language |
Acute postoperative pain |
Dolor agudo postoperatorio |
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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 | LLT |
E.1.2 | Classification code | 10036236 |
E.1.2 | Term | Postoperative pain relief |
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 |
To assess the analgesic efficacy of morphine chloride added to intradural local anesthetics at low doses in patients undergoing haemorrhoidectomy as compared to standard doses of intradural local anesthetics. |
Evaluar la eficacia analgésica de la adición de cloruro mórfico a una solución de anestésico local intradural a dosis bajas en comparación con las dosis estándar de anestésico en pacientes sometidos a hemorroidectomía. |
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E.2.2 | Secondary objectives of the trial |
Evaluate if the morphine chloride added to intradural local anesthetic at low doses in patients undergoing haemorrhoidectomy can produce: -Early mobility of patients -Less adverse events -Shortening the patient's hospital stay |
Evaluar si la adición de cloruro mórfico a una solución de anestésico local intradural a bajas dosis en pacientes sometidos a hemorroidectomía en régimen de hospitalización produce: -Una movililización más temprana del paciente -Menores efectos adversos -Un acortamiento de la estancia hospitalaria del paciente |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Patients undergoing haemorrhoidectomy -Age: 18-65 years old -Males and females. -ASA (American Society of Anesthesiology Classification) I to III. -Spinal bolck indication -Signed Informed Consent |
-Pacientes que van a ser sometidos a hemorroidectomía. -Edad entre 18 y 65 años -Ambos sexos. -ASA I a III. -Con indicación para bloqueo intradural. -Que otorguen el consentimiento informado |
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E.4 | Principal exclusion criteria |
-Patients with allergy to study drugs. -Patients with any contraindication to performing a spinal technique. -Patients with previous neurological disorders. |
-Pacientes con alergias a los medicamentos del estudio. -Pacientes con cualquier contraindicación para la realización de una técnica intradural (alteraciones de la coagulación, fiebre, hipertensión intracraneal, absceso en la zona de punción, etc.). -Pacientes con alteraciones neurológicas previas. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Analgesic effect measured by a visual analgesic scale |
Efecto anlagésico medido con la escala analgésica visual (EVA) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
In the resuscitation unit, 10 and 30 minutes after the surgery, 24 hours after the surgery and daily until 7 days from surgery. |
A la llegada a reanimación, a los 10 y 30 minutos, a las 24 horas y diariamente hasta 7 días tras la intervención. |
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E.5.2 | Secondary end point(s) |
a) Total of analgesic doses taken b) Degree of motor impairment c) Adverse events |
a) Número total de dosis anlagésicas recibidas b) Puntuación de bloqueo motor en el postoperatorio c) Acontecimientos adversos |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
a) 7 days from surgery b)At the arrival to the resuscitation unit c)Anytime over the study period |
a) A los 7 días de la interveción b) A su llegada a reanimación c) A lo largo de todo el período del estudio |
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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 | 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) | 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 | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
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
| 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
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The last visit of the last subject undergoing the trial |
Se considerará la finalización del ensayo clínico cuando se realice la última visita al último paciente reclutado. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |