E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute postoperative pain after gynaecologic surgery. |
Akuutti kipu gynekologisen alamahaleikkauksen jälkeen. |
|
E.1.1.1 | Medical condition in easily understood language |
Acute postoperative pain after gynaecologic surgery. |
Akuuttin gynekologisen alamahaleikkauksen jälkeinen kipu. |
|
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 the analgesic efficacy and safety of epidural oxycodone. |
Selvittää oksikodonin kivunlievitystehoa ja turvallisuutta epiduraalisen annon jälkeen. |
|
E.2.2 | Secondary objectives of the trial |
To assess the safety of epidural oxycodone. |
Selvittää oksikodonin turvallisuutta epiduraalisen annon jälkeen. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Women aged 18–75 yr undergoing elective gynaecological surgery with planned postoperative epidural analgesia. Patients must provide written consent. |
18-75-vuotiaat naiset, jotka tulevat elektiiviseen gynekologiseen alamahaleikkaukseen, ja joiden kivunhoito suunniteltu toteutetavaksi epiduraalisesti. Potilaiden tulee antaa kirjallinen suostumus. |
|
E.4 | Principal exclusion criteria |
Patient is unwilling to give consent, has allergy/hypersensitivity to oxycodone or other ingredients in the formulations, has reduced respiratory function, has defects in the vertebral column that are likely to hinder the placement of epidural and spinal catheters, is pregnant or nursing, has a tendency for bleeding or is currently on an anticoagulant therapy, or who has used oxycodone during the previous week, or MAO, CYP3A, or CYP2D6 inhibitors during the previous month, cancer surgery. |
Potilas ei anna suostumusta, allergia tai yliherkkyys oksikodonille tai valmisteen sisältämille ainesosille, heikentynyt hengitystoiminta, selän rakennevika, jonka arvioidaan merkittävästi vaikeuttavan lannepistoa, raskaus ja imetys, verenvuototaipumus tai käytössä oleva veren hyytymistä estävä lääkitys, on käyttänyt oksikodonia edellisen viikon aikana tai MAO, CYP3A tai CYP2D6 estäjiä edellisen kuukauden aikana, syöpäleikkaus. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The need for rescue analgesics (total dose of i.v. fentanyl, mg) during the first four hours after surgery. |
Lisäkipulääkkeen tarve (i.v. fentanyylin kokonaismäärä, mg) ensimmäisen neljän tunnin aikana leikkauksen jälkeen. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At four hours after surgery. |
Neljä tuntia leikkauksen jälkeen. |
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E.5.2 | Secondary end point(s) |
The time to first need for rescue analgesics, pain scores on 11-point numeric rating scale (NRS, 0=no pain, 10=most pain), adverse effects and the concentration of oxycodone in cerebrospinal fluid (CSF), one CSF sample per patient. |
Aika ensimmäiseen lisäkipulääkeannokseen, kipuarvot 11-portaisella numeerisella asteikolla (NRS, 0=ei kipua, 10=kovin kipu), haittavaikutukset ja oksikodonin pitoisuus aivoselkäydinnesteessä (likvor), jokaiselta potilaalto otetaan yksi likvornäyte. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The pain scores and adverse effects are recorded every 30 minutes during the first four hours after surgery, in the first postoperative evening in the ward and at 24 hours after surgery. The CSF samples are taken at four hours after surgery at the post-anesthesia care unit (PACU) before transmission to surgical ward. |
Kipuarvot ja haittavaikutukset kirjataan 30 minuutin välein ensimmäisen neljän tunnin aikana leikkauksen jälkeen, ensimmäisenä leikkauksen jälkeisenä iltana osastolla ja 24 tuntia leikkauksen jälkeen. Likvornäytteet otetaan neljä tuntia leikkauksen jälkeen heräämössä ennen osastolle siirtoa. |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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 | 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) | 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |