E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic pain after inguinal hernia surgery and knee replacement surgery. |
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E.1.1.1 | Medical condition in easily understood language |
Chronic pain after surgery. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
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 prevent the development of chronic postoperative pain after inguinal hernia surgery and knee replacement surgery and to to further explore the mechanism behind the development of chronic postoperative pain. |
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E.2.2 | Secondary objectives of the trial |
To explore the relationship between the pre-operative presence of CPM and central sensitisation in pre-operative pain free patients (inguinal hernia surgery) and in patients with chronic pain pre-operatively (osteoarthritis patients planned for knee replacement surgery) on the development of chronic postoperative pain. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients scheduled for elective inguinal hernia surgery or knee replacement surgery (to assess the severity of the knee osteoarthritis the Kellgren and Lawrance criteria will be used; see appendix 1). 2. American Society of Anesthesiologists score 1, 2 or 3 3. Age between 18-80 years
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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 (except for knee pain in patients planned for knee replacement surgery); 2. Regular use of anti-depressants or anti-epileptics for any purpose, including SNRIs and gabapentinoids 3. Known allergies or contraindication to the study medication according to the SmPC (such as the presence of respiratory depression, severe astma, paralytic ileus and acute intoxications with alcohol, hypnotics or other psychotropic active substances); 4. The presence of any chronic pain disorder; 5. Pregnancy/lactation; 6. Use of MAO-inhibitors or rifampicin within the last 14 days before inclusion; 7. Inability to perform psychophysical testing (eg. in case of cognitive or psychiatric disorders); 8. Inability to give informed consent; 9. Inability to communicate with the investigators.
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E.5 End points |
E.5.1 | Primary end point(s) |
(1) The effect of tapentadol compared to placebo on the development of chronic pain in the first year after surgery; |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
3, 6 and 12 months after surgery. |
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E.5.2 | Secondary end point(s) |
(1) The influence of the pre-operative pain profile on the development of chronic postoperative pain; (2) The influence of tapentadol and placebo on the individual pain profiles and its influence on the development of chronic postoperative pain. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1, 3, 6 and 12 months after surgery. |
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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 | 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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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 | |