| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Postoperative pain |
| Dolor postoperatorio |
|
| E.1.1.1 | Medical condition in easily understood language |
| Postoperative pain |
| Dolor postoperatorio |
|
| 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 establish which of the two strategies for treatment of postoperative pain (regional neuraxial anesthesia with morphic chloride and incisional catheters type On-Q) is more effective and safe in patients electively submitted to open surgery of hepatic or pancreatic pathology.
To compare the analgesic efficacy defined as EVA at 24 hours after surgery less than or equal to 3 points out of 10 |
Establecer cuál de las dos estrategias para tratamiento de dolor postoperatorio (anestesia regional neuroaxial con cloruro mórfico y catéteres incisionales tipo On-Q) es más eficaz y segura en pacientes sometidos de manera electiva a cirugía abierta de patología hepática o pancreática.
Comparar la eficacia analgésica definida como EVA a las 24 horas de la cirugía menor o igual a 3 puntos sobre 10 |
|
| E.2.2 | Secondary objectives of the trial |
- Establish intravenous morphic chloride consumption during the first three postoperative days in both groups.
- Collect the EVA score with cough and at rest at the exit of the operating room, at 12 hours after the end of surgery, at 24 hours, at 48 hours and at 72 hours.
- Incidence of side effects and complications (isolated nausea, respiratory depression, pruritus, isolated vomiting, dizziness, paralytic ileus) in both groups.
- Duration of hospital stay in days. |
- Establecer el consumo de cloruro mórfico intravenoso durante los tres primeros días postoperatorios en ambos grupos.
- Recoger la puntuación de EVA con la tos y en reposo a la salida de quirófano, a las 12 horas del final de la cirugía, a las 24 horas, a las 48 horas y a las 72 horas.
- Incidencia de efectos secundarios y complicaciones (náuseas aisladas, depresión respiratoria, prurito, vómitos aislados, mareo, íleo paralítico) en ambos grupos.
- Duración de estancia hospitalaria en días. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
- Age between 18 and 75 years
- Hepatic or pancreatic pathology that is going to be operated through open scheduled surgery at the La Paz university hospital (hepatic resection or pancreatic resection with Whipple type reconstruction).
- Sign informed consent. |
- Edad entre 18 y 75 años
- Patología hepática o pancreática que va a ser intervenida mediante cirugía programada abierta en el hospital universitario La Paz (resección hepática o resección pancreática con reconstrucción tipo Whipple).
- Firmar el consentimiento informado. |
|
| E.4 | Principal exclusion criteria |
● Patients allergic to local anesthetics.
● Patients classified as ASA IV.
● Patients diagnosed with mental retardation (communicative disability with the researcher).
● Technical impossibility to carry out spinal anesthesia (scoliosis, postsurgical manipulation of the lumbar spine and / or lipoma).
● Patients previously operated on for open surgery by midline laparotomy.
● Personal history of chronic use (more than 1 month) of opioids.
● Patients with chronic renal failure (estimated glomerular filtration rate less than 60 ml / min / 1.73 m2 and / or creatinine greater than 1.5 mg / dl.
● Patients diagnosed with epilepsy (treated with antiepileptic drugs for more than 1 year).
● Patients with hepatic impairment (Child B Classification and / or C in the last month).
● Patients with morbid obesity (BMI greater than 39).
● Patients diagnosed with obstructive sleep apnea syndrome who are being treated with nocturnal CPAP.
● Patients who according to the investigator's criteria will not be able to perform the study procedures. |
● Pacientes alérgicos a anestésicos locales.
● Pacientes clasificados como ASA IV.
● Pacientes diagnosticados de retraso mental (incapacidad comunicativa con el investigador).
● Imposibilidad técnica para llevar a cabo la anestesia raquídea (escoliosis, instrumentalización posquirúrgica de columna lumbar y/o lipoma).
● Pacientes intervenidos previamente de cirugía abierta por laparotomía media.
● Antecedentes personales de uso crónico (más de 1 mes) de opioides.
● Pacientes con insuficiencia renal crónica (filtrado glomerular estimado menor de 60 ml/min/1,73 m2 y/o creatinina mayor de 1,5 mg/dl.
● Pacientes diagnosticados de epilepsia (en tratamiento con antiepilépticos durante más de 1 año).
● Pacientes con insuficiencia hepática (Clasificación Child B y/o C en el último mes).
● Pacientes con obesidad mórbida (IMC mayor de 39).
● Pacientes diagnosticados de síndrome de apnea obstructiva del sueño que estén en tratamiento con CPAP nocturna.
● Pacientes que a criterio del investigador no vayan a ser capaces de realizar los procedimientos del estudio. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The primary objective of the study will be the EVA 24 hours after the end of surgery. It will be considered effective when the patient has an EVA score less than or equal to 3/10 at 24 hours. |
| El objetivo primario del estudio será el EVA a las 24 horas de finalizar la cirugía. Se considerará eficaz cuando a las 24 horas el paciente tenga una puntuación EVA menos o igual a 3/10. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| 24 hours post operation |
| A las 24 horas postoperatorias |
|
| E.5.2 | Secondary end point(s) |
- The milligrams of intravenous morphine chloride administered during the first three postoperative days will be evaluated.
- Pain at rest and with cough up to five times using the EVA scale: at the exit of the operating room (at 0 o'clock), at 12 o'clock, at 24 o'clock, at 48 o'clock and at 72 o'clock at the end of the intervention.
- The safety of analgesic strategies monitoring the appearance of adverse effects such as hypotension, respiratory depression, nausea, vomiting and paralytic ileus (hours from the onset of tolerance to the emission of gases and / or feces).
- Duration of hospital stay in days. |
- Se evaluarán los miligramos del cloruro mórfico intravenosos administrados durante los tres primeros días postquirúrgicos.
- Dolor en reposo y con la tos hasta en cinco ocasiones mediante la escala EVA: a la salida del quirófano (a las 0 horas), a las 12 horas, a las 24 horas, a las 48 horas y a las 72 horas del final de la intervención.
- La seguridad de las estrategias analgésicas monitorizando la aparición de efectos adversos como hipotensión, depresión respiratoria, náuseas, vómitos e íleo paralítico (horas desde el inicio de tolerancia hasta la emisión de gases y/o heces).
- Duración de la estancia hospitalaria en días. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| At zero hours, at 12 hours and 72 hours after the operation. |
| A las 0 horas, a las 12 horas y a las 72 horas postoperatorias. |
|
| 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 | 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) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description |
| Bupivacaína y cloruro mórfico intratecal |
| Intrathecal bupivacaine and morphic chloride |
|
| 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
|
| LVLS |
| Ultima visita del ultimo paciente |
|
| 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 | 9 |
| E.8.9.1 | In the Member State concerned days | |
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