E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Women who are scheduled for breast cancer surgery. |
Rintasyövän vuoksi leikkaukseen tulevat naiset. |
|
E.1.1.1 | Medical condition in easily understood language |
Women who will undergo surgery for breast cancer. |
Rintasyövän vuoksi leikkaukseen tulevat naiset. |
|
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 assess plasma concentrations of oxycodone and its main metabolites that provide satisfactory pain relief after breast cancer surgery. |
Selvittää plasma oksikodonin ja sen metaboliittien pitoisuudet, joilla saavutetaan riittävä kivun livittyminen |
|
E.2.2 | Secondary objectives of the trial |
To assess how much oxycodone is needed during the first 20 postoperative hours for pain relief after breast cancer surgery. |
Selvittää kuinka paljon oksikonia tarvitaan rintasyöpäleikkauksen jälkeen ensimmäisten 20 tunnin aikana. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Women, aged 18-75 years, who have breast cancer and who are scheduled to have breast resection or mastectomy with or without axillary clearance and who sign an informed consent form. |
Rintasyöpäleikkaukseen tulevat 18-75-vuotiaat naiset, joille tehdään joko rinnan resektio tai poisto kainaloevakuaation kera tai ilman ja jotka allekirjoittavat tietoon perustuvan suostumuksen. |
|
E.4 | Principal exclusion criteria |
Patients who have known metastases (other than axillary lymph nodes), who have clinically relevant kidney or liver failure or who are allergic to oxycodone. |
Potilaat, joilla on metastasoitunut tauti (lukuun ottamatta kainaloimusolmukkkeita), joilla on kliinisesti merkittävä munuaisten tai maksan vajaatoiminta tai jotka ovat yliherkkiä oksikodonille. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Satisfactory pain relief. |
Riittävä kivun livitys. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Patients will be administered oxycodone 0.05 mg/kg intravenously if needed every 5 minutes until satisfactory pain relief is achieved. At this point pain intensity is assessed with visual analogue scale (VAS) and blood is drawn for future assessment of plasma oxycodone & metabolite concentrations. Aftr this pain intenisty is assessed every 5 minutes until 15 minutes and thereafter every 15 minutes until th patient requested a further dose of analgesic. At this point pain is measured with VAS and blood is drawn after which oxycodone is adminsitered. |
Potilaille annetaan tarvittaessa laskimoon oksikodonia 0.05 mg/kg 5 minuutin välein kunnes potilas on tyytyväinen kivun lievitykseen. Tällöin mitataan kivun voimakkuus visuaalisella analogiasteikolla (VAS) ja otetaan verinäyte myöhemmin tehtävää plasman oksikodonin ja sen metaboliittien määritystä varten. Tämän jälkeen kivun voimakkuutta kysytään 5 minuutin välein kunnes 15 minuuttiin asti ja sen jälkeen 15 minuutin välein kunnes potilas tarvitsee seuraavan kerran kipulääkettä. Tuolloin mitataan kivun voimakkuus ja otetaan verinäyte, minkä jälkeen annetaan oksikodonia 0.05 mg/kg laskimoon. |
|
E.5.2 | Secondary end point(s) |
Total amount of oxycodone consumed in the postanaesthesia care unit and thereafter on the ward via a PCA (patient controlled analgesia) device during 20 hours from surgery. |
Oksikodonin kokonaiskulutus heräämövaiheen aikana sekä osastolla potilaan itseannostelulaitteen (PCA) avulla leikkauksen jälkeisten 20 tunnin aikana. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
20 hours after surgery. |
20 tuntia leikkauksen jälkeen |
|
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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
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 | No |
E.8.1.1 | Randomised | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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
|
The study regarding acute postoperative pain ends when the patient is referred home. However, questionnaires are sent at regular intervals afterwards and the patient who develop moderate or severe chronic pain will be treated at the pain clinic. |
Akuutin kivun vaiheen tutkimus päättyy potilaidne kotiutuessa. Heille lähetetään säännöllisin välein kyselylomakkeita ja potilaat, jotka kehittävät kohtalisen tai sitä voimakkaamman kroonisen leikkauksenjälkeisen kivun, hoidetaan kipuklinikalla. |
|
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 | |