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the MASTER study


- candidate number22850
- NTR NumberNTR5445
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-sep-2015
- Secondary IDsP15.018 LUMC
- Public Titlethe MASTER study
- Scientific TitleShifting pain modulation towards anti-nociceptivity: Mechanism-specific pharmacological prevention of post sternotomy pain: the MASTER study
- ACRONYMN/A
- hypothesisAnti-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.
- Healt Condition(s) or Problem(s) studiedCoronary Artery Bypass Grafting (CABG), Chronic pain
- Inclusion criteriaPatients 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 criteria1. 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).
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2015
- planned closingdate1-jan-2018
- Target number of participants500
- InterventionsTwo 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
- 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 outcomeChronic pain development
- Timepoints1. 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.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. Albert Dahan
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Albert Dahan
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD9-sep-2015 - 6-dec-2015


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