E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pain after thoracoscopic surgery |
Smerter efter video-assisteret thorakoskopisk kirurgi |
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E.1.1.1 | Medical condition in easily understood language |
Pain after videoscopic pulmonary surgery |
smerter efter kikkert-lungekirurgi |
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E.1.1.2 | Therapeutic area | Body processes [G] - Bones and nerves physological processes [G11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036236 |
E.1.2 | Term | Postoperative pain relief |
E.1.2 | System Organ Class | 100000004865 |
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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 |
To show a supplemental analgesic effect of methylprednisolone on acute postoperative pain after video-assisted thoracig surgery |
At vise den supplerende analgetiske effekt af Methylprednisolon på akutte postoperative smerter efter video-assisteret lungekirurgi. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age > 18 yars. Scheduled for Video-assisted thoracoscopic lobectomy. Signed informed consent. |
Alder > 18 år. Patienter planlagt til VATS-lobektomi. Patienter, som har givet deres skriftlige informerede samtykke til at deltage i undersøgelsen efter at have forstået den givne information.
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E.4 | Principal exclusion criteria |
Cant co-operate to take part in the study. Do not speak or understand danish. Not scheduled for follow-up in the Rigshospitalet. Allegies to any medicine used in the study. Symptomatic gastric ulcur. cardiac insufficiency (NYHA > 2). Reduced kidney function. Medical treated diabetes mellitus. Abuse of medicine and/or alcohol. Daily use of psycoactive drugs. Neurological disease that could influence the perception of pain. Breats feeding ore expecting mothers. Previously had thoragic surgery on the same side. Daily use of steroids in the period from three months before the operation til two days after the operation. |
Patienter som ikke kan samarbejde til undersøgelsen. Patienter som ikke forstår eller taler dansk. Patienter der ikke planlægges til postoperativ ambulant kontrol på Rigshospitalet. Allergi overfor de i undersøgelsen anvendte stoffer. Symptomgivende mavesår. Betydende hjerteinsufficiens (NYHA ≥ 3). Nedsat nyrefunktion. (Forhøjet P-kreatinin). Behandlingskrævende diabetes mellitus. Alkohol- og/eller medicinmisbrug – efter investigators skøn. Brug af psykofarmaka. Neurologisk sygdom, der vurderes at kunne påvirke patientens smerteperception. Graviditet eller ammende. Tidligere lungekirurgi på samme side. Fast forbrug af steroid i andre former end inhalationsmedicin (Forbrug af steroid i perioden fra 3 måneder før operation til 2 dage efter operation, vil medføre eksklusion). Fast forbrug af stærke smertestillende midler (opioider og opioidagonister).
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E.5 End points |
E.5.1 | Primary end point(s) |
Area under curve for pain scores at rest and after defined movements (numeric rating scale) 0 - 48 hours postoperative. |
Areal under kurve for smertescore i hvile og ved veldefineret bevægelse (numerisk rating skala)
0 – 48 timer postoperativt.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
continuously until 48 hours postoperative |
fortløbende indtil 48 timer postoperativt |
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E.5.2 | Secondary end point(s) |
Incidence of nausea and vomiting. Use of analgetics and anti-emetics. Localisation of pain. The position of the chest tube. Volume of drainage on the day of operation. Incidence of delayed wound healing. Incidence of infections in the postoperativ period. Fatigue. Sleep quality. Blood glucose on the day of operation. |
Incidens af kvalme og opkast. Forbrug af analgetika og anti-emetika. Smertelokalisation. Drænplacering. Output i dræn i operationsdøgnet. Incidens af forsinket sårheling. Incidens af postoperative infektioner. Fatigue (”trætbarhed”). Søvnkvalitet. Blodsukkerniveau i operationsdøgn. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Incidence of nausea and vomiting, use of analgetics and anti-emetics, localisation of pain, fatigue and sleep quality is followed until 48 hours postoperative. Blood glucose is measured in intervals of three hours during the day of operation. The position of the chest tube is registered at the end of the operation. Volume of drainage is assecced in the morning at the first postoperative day. Incidence of delayed wound healing and infektions is followed in 12 weeks after the operation. |
Incidens af kvalme og opkastninger, forbrug af analgetika og anti-emetika, smertelokalisation, fatigue og søvnkavalitet følges indtil 48 timer postoperativt. Blodsukkerniveau måleshver tredie time i operationsdøgnet. Drænplacering registreres ved endt operation. Out-put i dræn registreres om morgenen første postoperative dag. incidensen af forsinket sårheling og infektioner følges 12 uger postoperativt. |
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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 | 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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 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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Inclusion of 100 patients who had fulfilled the study protocol for the designated study period (last patient - last visit) |
Inklusion af 100 evaluerbare patienter, som har gennemført studiet i henhold til protokollen |
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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 | |
E.8.9.1 | In the Member State concerned days | |