E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
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 |
To see if Video-Assisted Thoracic Surgery (VATS) lobectomy, wedge- or segmental resection can be done without epidural analgesia with no or only minor side effects. |
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E.2.2 | Secondary objectives of the trial |
Side effects of thoracic epidural analgesia. Immonological aspects of use of epidural analgesia for VATS.
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
The immunological part of the trial will encompas only part of the total study population. |
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E.3 | Principal inclusion criteria |
Planned elective VATS lobectomy, wedge- or segmental resection (for the subsequent biomarker study, only lobectomy is a inclusion criteria, specified in protocol amendment July 27th 2016). Patient has accepted to have epidural analgesia as part of the anaesthesia for the procedure. Informed consent is attained. Patient is over 18 years of age. Patient is mentally able to answer questionnaires included in the study. |
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E.4 | Principal exclusion criteria |
Allergies to any of the medications used in the trial. History of previous peptic ulcer. History of chronic pain to any degree that will interfere with quantification of pain postoperatively. Dementia or reduced mental capacity to any degree that will interfere with quantification of pain postoperatively. Pregnancy. Contra-indications to placement of epidural catheter. Any concurrent cancer disease or use of immune modulating drugs (criteria added as part of a protocol amendment July 27th 2016 for a subsequent biomarkers study) |
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E.5 End points |
E.5.1 | Primary end point(s) |
1) Intensity of pain. Self reported pain intensity 5 times a day both at rest and during activity until chest tube is removed or day 4 after operation is reached.
2) Consumption "Rescue Analgesia" - i.v. opioids. The consumption of i.v. opioids is registered daily until chest tube is removed or day 4 after operation is reached. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Postoperative day 0 to 4. |
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E.5.2 | Secondary end point(s) |
Duration of surgery. Length of hospital stay. Time used placing epidural catheter. Procedural time and competence level of MD placing catheter. Side effects of epidural analgesia. Side effects observed using epidural analgesia including itching, nausea, vomiting, procedural pain, hypotension, dizziness, respiratory depression, reduced pulmonary function. Sequelae following VATS and placement of epidural catheter (Questionnaire and Postoperative survival). Questionnaire sent to patients 6, 12, 24 and 60 months after surgery (criteria edited as part of a protocol amendment July 27th 2016 for a subsequent biomarkers study). Immune cells . Time Frame: During surgery and one hour and 24 hours after surgery, and compared with pre-operative levels. NK-cells (levels and activity) will be examined as indicators of immunological response to surgery. Cytokines. Time Frame: During surgery and one hour and 24 hours after surgery, and compared with pre-operative levels. Levels of cytokines (IL-6, IL-10, IL-12 and IFN-gamma) will be examined as indicators of immunological response to surgery.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
During in-hospital stay (POD 0-4). For the questionnaire and survival part of the study the time frame is 60 months.
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
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 | 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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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 | |