E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Women who have been operated for pregnancy with caesarean section |
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E.1.1.1 | Medical condition in easily understood language |
Healthy pregnant women who have undergone a caesarean section |
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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 |
At our hospital, oxycodone is given orally to all woman who have had a caesarean section under regional anesthesia. Oxycodone is given orally when arriving to the postoperative care unit, and then again after 12 hours. The aim of this study is identify the amount of the IMP (oxycodone) that is actively taken up by the gut in the immediate postoperative period( 0, 1, 2 and 6 hours) by measuring the level of oxycodone in serum at specific periods and comparing it with degree of pain. |
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E.2.2 | Secondary objectives of the trial |
Possible differences in analgesic effect and degree of analgesia and its relation to the serum level of oxycodone. The speed of gastric emptying by measuring the level of paracetamol in serum at the same time periods |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthy women (ASA class 2) between 18 and 45 years with a single fetus undergoing an elective caesarean section under regional anesthesia. They must be at term (between 37+0 and 41+6 weeks pregnant), pre conception BMI (body mass index) between 18.5 and 24.9, height between 155 cm and 180 cm. They must have read and signed the written information. |
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E.4 | Principal exclusion criteria |
Known sensitivity against oxycodone. Women with pre conceptual other diseases (i.e ASA 3 or more) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Serum level of oxycondone and paracetamol as measured at points 0 (reference), 1, 2 and 6 hrs after administration of oxycodone and paracetamol. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Serum level of paracetamol at 0, 1, 2 and 6 hours Possible differences in analgesic effect as measured by NRS (Numeric Rating Scale) Possible side effects of oxycodone (nausea/vomiting, pruritus and/or sedation) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
0, 1, 2, and 6 hours postoperatively |
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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 | Yes |
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 | 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.8.2.4 | Number of treatment arms in the trial | 1 |
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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When the last of the planned 50 women have been measured at 6 hours |
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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 | |
E.8.9.1 | In the Member State concerned days | |