E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients undergoing oncological surgery and/or breast reconstruction surgery |
Pacientes sometidos a cirugía oncológica y/o reconstructiva de mama |
|
E.1.1.1 | Medical condition in easily understood language |
Patients undergoing oncological surgery and/or breast reconstruction surgery |
Pacientes sometidos a cirugía oncológica y/o reconstructiva de mama |
|
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 | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10042609 |
E.1.2 | Term | Surgery |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
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 use of opioid drugs during breast oncologic surgery and to analyze the efficacy of serratus plane block as a opiates-saving method. |
Evaluar el consumo de fármacos opiáceos durante la cirugía oncológica de mama y analizar la eficacia del bloqueo del serrato como método de ahorro de opiáceos. |
|
E.2.2 | Secondary objectives of the trial |
Evaluate the degree of post-operative analgesia measured by a visual analogue scale during the first 24 hours after the operation. - Analyze the need of opioid drugs administration in post-operative as a rescue analgesia as well as the time from the surgery until the first dose administered. - Register the appearance of side effects associated with opioids administration and value the correlation of the serratus block in the reduction of such effects frequency. - Value the occurrence of complications related with serratus block as well as the degree of patient satisfaction. |
Evaluar el grado de analgesia postoperatoria medida con una escala visual analógica durante las primeras 24 horas postoperatorias- Analizar la necesidad de administración de fármacos opiáceos en el postoperatorio como analgesia de rescate así como el tiempo que transcurre desde la cirugía hasta la primera dosis administrada.- Registrar la aparición de efectos secundarios relacionados con la administración de opiáceos y valorar la correlación del bloqueo del serrato en la disminución de la frecuencia de dichos efectos.- Valorar la aparición de complicaciones relacionadas con la realización del bloqueo del serrato así como el grado de satisfacción del paciente. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients older than 18 years, undergoing oncological surgery and/or breast reconstruction surgery whose pathology and surgical intervention supose at least a 24 hours hospital admission |
Pacientes mayores de 18 años, sometidos a cirugía oncológica y/o reconstructiva de mama cuya patología e intervención quirúrgica supone un ingreso de al menos 24 horas |
|
E.4 | Principal exclusion criteria |
ASA Physical Status Classification System? IV.- Morbid obesity (Body mass index >40). - Impossibility of anatomical structures ultrasound identification in a satisfactory way (there can be no distinction in the interfascial plane between serratus and pectoral muscle). ? Opioids treatment before surgery. ? Sepsis and/or infection at the puncture site. ? Haemostasis disorders. - Allergy to any of the drugs used in the study. |
Pacientes con Escala de riesgo anestésico-quirúrgico ASA ? IV.- Obesidad mórbida (Índice de masa corporal >40). - Imposibilidad de identificación ecográfica satisfactoria de las estructuras anatómicas (no se puede distinguir el plano interfascial entre músculo serrato y pectoral). - Tratamiento con opiáceos previo a al cirugía. - Sepsis y/o infección en el punto de punción. - Trastornos de la hemostasia. - Alergia a algunos de los fármacos utilizados en el estudio |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Opioids consumption |
Consumo de opioides |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
First 24 hours after surgery |
Primeras 24 horas tras la cirugía |
|
E.5.2 | Secondary end point(s) |
Postoperative pain measured by EVA (visual analogue scale) in the time. ? Time until the need for rescue analgesia. ? Appearance of postoperative complications (nausea/vomit, itch, apnea, urinary retention, paralytic ileus). ? Gender, age, surgical risk ASA, duration and type of surgery, weight, height, body mass index. |
Dolor postoperatoriao medido mediante una escala EVA en el tiempo. ? El tiempo hasta necesidad de analgesia de rescate. ? Aparición de complicaciones en el postoperatorio (nausea/vómito, prurito, apnea, retención urinaria, íleo paralítico.- Sexo, edad, riesgo quirúrgico ASA, duración y tipo de cirugía, peso, talla, índice de masa corporal. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
First 24 hours after surgery |
Primeras 24 horas tras la cirugía |
|
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 | 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 | 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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Anestesia convencional |
Conventional anesthesia |
|
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
|
|
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 | |
E.8.9.1 | In the Member State concerned days | |