No registrations found.
ID
Source
Brief title
Health condition
Coronary bypass, chronic pain, duloxetine, pregabalin, placebo
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Pain on visual analogue scale (VAS)
- Conditioned pain modulation (CPM)
- STAI (State-Trait Anxiety Inventory)
- PCS (Pain Catastrophizing Scale)
- The Big Five Inventory (BFI)
- Hospital Anxiety and Depression Score (HADS)
Secondary outcome
Chronic pain development
Background summary
The preoperative balance between anti- and pronociception may play a crucial role in the development of chronic postoperative pain. Improvement of the preoperative nociceptive profile of the patient may reduce the risk of developing postoperative pain. To test this hypothesis this study is designed to study the effect of preoperative administration of duloxetine and pregabalin on the development of chronic postoperative pain.
Study objective
Anti-nociception is an existing or attainable state of pain modulation that can be reached by specific pharmacological agents coupled to individual patterns of pain modulation. Being in, or shifted into anti-nociception state of pain modulation, minimizes pain morbidity.
Study design
1. Conditioned pain modulation (CPM) and offset analgesia (OA) will be measured 2 weeks before surgery and two days before surgery.
2. After surgery we will record pain intensity and analgesic consumption during the first 3-5 days.
3. two-weekly chronic post-operative pain and analgesic use will be pursued for 3 months and once more after one year.
Intervention
Two weeks before elective surgery patients will be treated with duloxetine 60mg, pregabalin 150mg or a placebo.
The influence of these treatments on the endogenous pain control will be evaluated
Department of Anesthesiology,
P.O. Box 9600
Albert Dahan
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
a.dahan@lumc.nl
Department of Anesthesiology,
P.O. Box 9600
Albert Dahan
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
a.dahan@lumc.nl
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.
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 (e.g. in case of cognitive or psychiatric disorders);
7. Patients suffering from cognitive dysfunction;
8. Patients currently 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5336 |
| NTR-old | NTR5445 |
| Other | LUMC : P15.018 |