Het verschuiven van pijn modulatie naar pijnstilling: mechanisme-specifieke farmacologische preventie van post-sternotomie pijn: de MASTER studie

• Conditions: chronic pain; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2014-005701-20-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-02
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified