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the MASTER study

Shifting pain modulation towards anti-nociceptivity: Mechanism-specific pharmacological prevention of post sternotomy pain: the MASTER study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22036
Enrollment
500
Registered
2015-09-09
Start date
2015-10-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary bypass, chronic pain, duloxetine, pregabalin, placebo

Interventions

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

Sponsors

Leiden University Medical Center (LUMC)
Lead Sponsor

Eligibility

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.

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 (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 outcomes

Primary

MeasureTime frame
- 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

MeasureTime frame
Chronic pain development

Contacts

Public ContactAlbert Dahan

Leiden University Medical Center (LUMC), Department of Anesthesiology, P.O. Box 9600

a.dahan@lumc.nl+31 (0)71 5262301

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)