E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
female patients in need of getting an abdominal hysterectomy due to an illness |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000075 |
E.1.2 | Term | Abdominal hysterectomy |
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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 |
postoperativ opioid consumption via patient controlled analgesia (PCA) through 24 h |
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E.2.2 | Secondary objectives of the trial |
strength of resting pain (numerical rating scale) strenght of coughing pain (numerical rating scale) strength of pain under load (numerical rating scale) Symptom Distress Scale (SDS) patient's satisfaction with pain therapy patient's satisfaction with perioperative course rating of pain therapy by physician and nursing staff german version Gastrointestinal Quality of Life Index (GiQLI) quality of Life via Short-Form 36 (SF-36) transcutaneous oxygen nightly apnoe ECG point in time of first getting up days of incapacity of work resp. homework duration of PCA therapy
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
female with minimal age of 18 years need to undergo abdominal hyterectomy under general anesthesia written informed consent given
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E.4 | Principal exclusion criteria |
• mechanical obstipation • mechanical urinary retention • gangrene • dystophia myotonica • depolarization block after application of depolarizing muscle relaxant • intoxication by depolarizing muscle relaxant of the Suxamethonium type • intoxication by irreversible acting cholinesterase inhibitors • enclosed craniocerebral injury • obstruction of the gastrointestinal tract and the revulsive urinary tract • current known allergic asthma bronchial or hostory of allergic asthma bronchiale • current serious diseases according ASA score > II esp. cardio- or cerebral vascular or pulmonary diseases • incapability of giving informed consent • current regular analgesic intake (opioids WHO III or NSAID/non-opioids for > 15 days/months or daily intake for the 7 last days) • Anaphylaxis on the active component or any athor component of Anticholium, Physostigminsalicylat (Ph.EUR.), Natriummetabisulfat (Ph.EUR.), placebo, Dipidolor, Metamizol or any other component of the IMP • Any surgery with persitent complaints within the last 2 months (exemption conization) • Recent history (6 months) or current evidence of alcohol or drug abuse; • Participation iin any other investigational drug therapy study within the last 90 days • Breastfeeding women • Body weight above 130 kg |
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E.5 End points |
E.5.1 | Primary end point(s) |
consumption of morphin via PCA |
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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 | No |
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) | 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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
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 | Information not present in EudraCT |
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
|
last interview of the last subject |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |