E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients selected for tonsillectomy |
Pacientes selecionados para amigdalectomia |
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E.1.1.1 | Medical condition in easily understood language |
Patients selected for tonsillectomy |
Pacientes selecionados para amigdalectomia |
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E.1.1.2 | Therapeutic area | Diseases [C] - Ear, nose and throat diseases [C09] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10044006 |
E.1.2 | Term | Tonsillectomy |
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 compare the effect of the association of local infiltration of ropivacaine and dexamethasone alone or in combination with the reduction of pain and the need for supplemental analgesia after tonsillectomy in the immediate and late postoperative period in individuals aged 18-65 years.
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Comparar o efeito da associação de infiltração local de ropivacaína e dexametasona, isoladamente ou em associação, na redução da dor e da necessidade de analgesia suplementar, após amigdalectomia, no período pós-operatório imediato e tardio, em indivíduos, dos 18 aos 65 anos. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the recovery in the postoperative period as well as the possible occurrence of complications associated with the use of the pre-incisional infiltration technique in tonsillectomy. |
Avaliar a recuperação no período pós-operatório assim como a eventual ocorrência de complicações associadas à utilização da técnica de infiltração pré-incisional na amigdalectomia. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- American Society of Anesthesiologists (ASA) physical status I-II; - Surgical proposal of tonsillectomy; - Tonsillectomy performed by the cold shedding technique; - History of recurrent tonsillitis, caseous tonsillitis and / or peritonsillar abscess; |
- American Society of Anesthesiologists (ASA) physical status I-II; - Proposta cirúrgica de amigdalectomia; - Realização de amigdalectomia pela técnica de disseção a frio; - Antecedentes de amigdalites de repetição, amigdalite caseosa e/ou abcesso periamigdalino;
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E.4 | Principal exclusion criteria |
- Use of chronic analgesic medication; - ASA III-IV; - Coagulation disorders; - Intolerance or allergy to any of the drugs used in the study; - Suspected neoplastic disease; - Fever or acute respiratory tract infection in the last 3 weeks; |
- Utilização de medicação analgésica crónica; - ASA III-IV; - Distúrbios da coagulação; - Intolerância ou alergia a algum dos fármacos utilizados no estudo; - Suspeita de doença neoplásica; - Febre ou infeção aguda das vias respiratórias nas últimas 3 semanas; |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Alteration in Visual Analogue Scale values applied at rest and during swallowing;
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- Alteração nos valores da Escala Visual Analógica aplicada em repouso e durante a deglutição;
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
clinical visit |
visita clínica |
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E.5.2 | Secondary end point(s) |
- Time to first administration of analgesia; - Time to onset of water intake and liquid and solid oral diet |
- Tempo até a primeira administração de analgesia; - Tempo até ao início de ingestão de água e dieta oral líquida e sólida |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
clinical visit |
visita clínica |
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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) | 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) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
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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LVLS |
última visita do último participante. |
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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 | 12 |
E.8.9.1 | In the Member State concerned days | |