Effects of pain relievers on heart and blood vessel function
Effect of Opioids and NSAIDs on Sympathetic Nervous System and Vascular Function in Healthy Subjects and Patients With Osteoarthritis
This study is testing how different pain relievers affect heart and blood vessel function in people with osteoarthritis and healthy individuals to see if they are safe for those over 35 who have chronic pain.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Locations | 1 site (Zurich) |
| Trial ID | NCT03781544 on ClinicalTrials.gov |
What this trial studies
This study evaluates how different pain-relieving medications, specifically Tramadol, Paracetamol, and Diclofenac, affect sympathetic nerve activity, blood pressure, heart rate, and vascular function in patients with osteoarthritis and healthy individuals. It aims to address the cardiovascular safety concerns associated with these analgesics, particularly in patients over 35 years old who suffer from chronic pain and may have cardiovascular risks. By investigating the differential effects of these medications, the study seeks to provide insights that could guide better pain management strategies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of osteoarthritis or healthy individuals of the same age.
Not a fit: Patients with a history of cardiovascular events or significant health issues that could interfere with the study may not benefit.
Why it matters
Potential benefit: If successful, this study could lead to safer pain management options for patients with osteoarthritis and cardiovascular concerns.
How similar studies have performed: Other studies have explored the cardiovascular effects of pain relievers, but this specific investigation into the differential effects of NSAIDs and opioids is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients ≥ 18 years of age, male or female, with a diagnosis of osteoarthritis or healthy subjects ≥ 18 years of age; 2. Written informed consent; Exclusion criteria: 1. History of hypersensitivity or allergy to any of the study drugs 2. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major CV surgery, percutaneous coronary intervention (PCI) or carotid angioplasty within the 3 months prior to Visit 1; 3. Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 3 months after Visit 1; 4. Presence of significant endocrine diseases; 5. Presence of active acute infectious diseases; 6. Known narrow-angle glaucoma; 7. Known epilepsy; 8. Cimino-shunt operation on both arms; 9. Pregnancy, intention thereof during study, lack of sufficient contraception, breastfeeding; 10. Drug or alcohol abuse;
Where this trial is running
Zurich
- University Heart Center Zurich — Zurich, Switzerland (Recruiting)
Study contacts
- Study coordinator: Isabella Sudano, MD
- Email: Isabella.Sudano@usz.ch
- Phone: +41442555841
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.