E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
For at evaluere sikkerheden og muligheden for dosisoptimering ved topisk administreret ropivacain, ønsker vi at måle serumkoncentrationen af lægemidlet i blodprøver fra patienter, der behandles med gentagne bolusinjektioner med ropivacain som postoperativ smertebehandling efter osteosyntese (operation med skruer og skinner) af hoftenært lårbensbrud af pertrochantær type. |
|
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 | 10034736 |
E.1.2 | Term | Pertrochanteric fracture of femur, closed |
|
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 evaluere sikkerheden ved topisk administreret ropivacain til patienter, der behandles med gentagne bolusinjektioner med ropivacain som postoperativ smertebehandling efter osteosyntese af hoftenært lårbensbrud af pertrochantær type. |
|
E.2.2 | Secondary objectives of the trial |
At evaluere muligheden for dosisoptimering ved behandling med gentagne bolusinjektioner med ropivacain som postoperativ smertebehandling efter osteosyntese af hoftenært lårbensbrud af pertrochantær type. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Pertrochantær femurfraktur og indikation for DHS-osteosyntese. Hver patient kan kun indgå med 1 hoftefraktur. Patienterne skal have gangfunktion (patienten angiver normalt at kunne gå med eller uden hjælpemidler). Kun frakturer opstået ved lavenergitraumer kan indgå. Patienterne skal kunne forstå dansk og være i stand til selv at give informeret samtykke. Patienter med OMC < 8 (kognitiv test) kan ikke deltage. Patienter med hoftenær lavenergifraktur er typisk ældre end 60 år gamle. Det er ikke sandsynligt, at patientgruppens kvinder er fertile. Skulle en kvinde i den fertile alder inkluderes i projektet, skal der inden inklusion i forsøget foretages graviditetstest, som skal være negativ
|
|
E.4 | Principal exclusion criteria |
Inverse frakturer ekskluderes. Fast forbrug af opioider. Allergi mod lokalanalgetika. Inflammatorisk ledlidelse. Patologiske frakturer.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Serumniveau af Naropin (ropivacain). Tidspunkter for måling fremgår af projektprotokollen. |
|
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 | No |
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) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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
| |
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 | |
E.8.9.1 | In the Member State concerned days | |