chronic pain
Conditions
Interventions
Trade Name: Cymbalta
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Trade Name: Lyrica
Pharmaceutical Form: Capsule
Pharmace
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 290 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Pre-operative (day -14) Pre-operative (day -1) Post-operative (days 3-5);Main Objective: 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. ;Secondary Objective: 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.;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 cough | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Consumption of analgesics Pain assessment;Timepoint(s) of evaluation of this end point: Postoperative (up to one year postoperative) | — |
Countries
Netherlands
Contacts
Public ContactAlbert Dahan
Leiden University Medical Center
Outcome results
None listed