E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patienter der operativt får fjernet prostata pga. kræft. Efter operationen har patienterne behov for smertestillende behandling, ofte med morfin. Denne behandling kan have en række bivirkninger. Studiet undersøger effekten af Transversus Abdominis Plane blok, på postoperative smerter efter åben prostatektomi. Blokaden udføres med et kendt kendt lægemiddel, Ropivacain. Effekten undersøges ved at monitorere smertescore, morfinforbrug og bivirkningsscore de første 24 timer efter operationen. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054711 |
E.1.2 | Term | Postoperative pain |
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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 |
Vores formål er at undersøge effekten af Transversus Abdominis Plane (TAP) blokade som postoperativ smertestillende behandling efter åben prostatektomi. Vores hypotese er at TAP blokaden kan reducere smertescoren postoperativt sammenlignet med placebo. |
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E.2.2 | Secondary objectives of the trial |
At undersøge om TAP blokaden kan reducere det postoperative morfikaforbrug samt bivirkningsscore sammenlignet med infiltrationsanæstesi og placebo. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Alder > 18 år og < 80 år - Patienter indstillet til åben prostatektomi - Patienter, som har givet deres skriftlige informerede samtykke til at deltage i undersøgelsen efter at forstået protokollens indhold og begrænsninger fuldt ud. - ASA 1-3 - BMI > 18 og < 35 |
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E.4 | Principal exclusion criteria |
- Patienter der ikke kan samarbejde til undersøgelsen - Patienter der ikke forstår eller taler dansk - Allergi over for, de i undersøgelsen, anvendte stoffer - Alkohol- eller medicinmisbrug, efter investiagtors skøn - Kronisk smerte med dagligt indtag af opioidpræparater - Infektion ved indstiksstedet |
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E.5 End points |
E.5.1 | Primary end point(s) |
VAS (Visuel Analog skala) smertescore ved mobilisering (fra liggende til siddende stilling) fire timer postoperativt mellem TAP blok og placebo gruppe. |
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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 | No |
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) | 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) | 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
| 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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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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Der planlægges inkluderet i alt 75 evaluerbare patienter på hovedeffektmål. Forsøget er slut for den enkelte forsøgsperson 24 timer efter operation. |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
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 |