E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
chronic pain |
chronische pijn |
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E.1.1.1 | Medical condition in easily understood language |
chronic pain |
chronische pijn |
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E.1.1.2 | Therapeutic area | Body processes [G] - Physiological processes [G07] |
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 |
In this research project we explore anti-nociception as a state of pain modulation. Our main objectives in utilizing the plasticity of the central pain pathways are to: (i) Shift individuals from a pro-nociceptive pain modulation profile to an anti-nociceptive profile; (ii) Explore how this affects their chances of developing chronic pain; and (iii) Explore whether a pharmacologically induced shift towards an anti-nociceptive state is efficient in the prevention of chronic postoperative pain. |
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E.2.2 | Secondary objectives of the trial |
Specific aim (SA) 1: To explore the transition from pro-nociception to anti-nociception by augmenting pain inhibition or attenuating pain facilitation. SA 2: To explore whether a mechanism-specific shift of a pain modulatory profile (PMP) from pro- to anti-nociception yields better preemptive analgesia then mechanism non-specific one. SA 3: To explore whether pharmacologically induced shift from pro- to anti-nociception is as effective as innate anti-nociception in lowering post-operative pain. Additional points that could potentially be addressed by the proposed study, but will not be defined as specific aims, will include the question of the relative weight of shift to anti-nociception based on the inhibitory line compared to that based on the facilitatory line. We would also be interested to assess the effect of the non-specific effects of the study drugs. This is since these drugs have modes of action additional to their primary one, which might play a significant role. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients of either sex with American Society of Anesthesiologists score 1, 2 or 3, aged 18 to 70 years planned to undergo elective surgery involving a sternotomy may be enrolled in the study. |
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E.4 | Principal exclusion criteria |
1. Pain scores > 3 (on a 11-point numerical rating scale, NRS) reported for most of the day during the past month (including angina); 2. The presence of any chronic pain disorder; 3. Regular use of analgesics for any purpose, including SNRIs, gabapentinoids, COX inhibitors or NSAIDs during the previous month; 4. Use of MAO-inhibitors within the last 14 days; 5. The presence of narrow-angle glaucoma; 6. Inability to perform psychophysical testing (eg. in case of cognitive or psychiatric disorders); 7. Patients suffering from cognitive dysfunction; 8. Patients being treated for depression, or any other mood disorder; 9. Inability to give informed consent; 10. Inability to communicate with the investigators; 11. Known allergies to the study medication: 12. Uncontrolled hypertension (diastolic blood pressure > 100 mmHg).
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E.5 End points |
E.5.1 | Primary end point(s) |
Psychophysical assessments: temporal summation (TS) and conditioned pain modulation (CPM) Psychological assessments: anxiety level (Spielberger State-Trait Anxiety Inventory), pain catastrophizing (Pain Catastrophizing Scale), the Big Five Inventory, Hospital Anxiety and Depression Score Pain assessment at rest and during coughing (pain numerical rating scores) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Pre-operative (day -14) Pre-operative (day -1) Post-operative (days 3-5) |
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E.5.2 | Secondary end point(s) |
Consumption of analgesics Pain assessment |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Postoperative (up to one year postoperative) |
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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 | Yes |
E.6.3 | Therapy | No |
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) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 2 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
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 | 3 |
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 |