Effects of Opioids and NSAIDs on Sympathetic Nervous System and Vascular Function

NCT03781544 | Recruiting Phase 4

• 1 other identifier: OPIOVASC
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the effect of different analgesic treatments (Tramadol, Paracetamol, Diclofenac) on sympathetic nerve activity, blood pressure, heart rate, heart rate, and vascular function in osteoarthritis patients and healthy subjects.

Conditions

Osteoarthritis of Multiple Joints of Ankle or Foot; Healthy

Outcome Measures

Primary Outcomes (2)

• resting MSNA (sympathetic nervous activity )

  Effect of different single analgesic treatments (Tramadol, Paracetamol, Diclofenac) on resting muscle sympathetic nerve activity (MSNA) in osteoarthritis patients (post 2 days of analgesic therapy washout phase) and in healthy subjects. Tramadol treatment will be compared to diclofenac and paracetamol (3 treatment arms). 90 participants (45 osteoarthritis patients, 45 healthy subjects); Single infusion of Tramadol (50 mg i.v.) Single infusion of Paracetamol (1000 mg i.v.) Single infusion of Diclofenac (75 mg i.v.)

  1day (110 min)

• changes in FMD (Flow mediated vasodilation)

  Effect of a single acute intravenous analgesic treatment with tramadol versus paracetamol on changes in flow mediated dilatation (FMD) in osteoarthritis patients and in healthy subjects. Tramadol treatment will be compared with paracetamol as we previously demonstrated that paracetamol exerts no significant effects on endothelial function as measured by flow mediated dilatation. 80 participants (40 osteoarthritis patients, 40 healthy subjects); Single infusion of Tramadol (50 mg i.v.) Single infusion of Paracetamol (1000 mg i.v.)

  1 day (210min)

Study Arms (3)

Diclofenac

EXPERIMENTAL

Diclofenac (Diclofenacum natricum) A single i.v. infusion of Diclofenac (dose: 75mg/100ml) will be administered to the participants (treatment arm).

Drug: Diclofenac

Paracetamol

ACTIVE COMPARATOR

Paracetamol (Paracetamol Sintetica): A single i.v. infusion of Paracetamol (dose: 1g/100ml) will be administered to the participants (control arm).

Drug: Paracetamol

Tramadol

EXPERIMENTAL

Tramadol (Tramadol-Mepha): A single i.v. infusion of Tramadol (dose: 400mg/100ml) will be administered to the participants (treatment arm).

Drug: Tramadol

Interventions

Tramadol DRUG

A single i.v. infusion of Tramadol (dose: 400mg/100ml) will be administered to the participants (treatment arm).

Also known as: Tramadol-Mepha

Tramadol

Paracetamol DRUG

A single i.v. infusion of Paracetamol (dose: 1g/100ml) will be administered to the participants (control arm).

Also known as: PARACETAMOL Sintetica

Paracetamol

Diclofenac DRUG

A single i.v. infusion of Diclofenac (dose: 75mg/100ml) will be administered to the participants (treatment arm).

Diclofenac

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years of age, male or female, with a diagnosis of osteoarthritis or healthy subjects ≥ 18 years of age;
• Written informed consent;

You may not qualify if:

• History of hypersensitivity or allergy to any of the study drugs
• 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;
• Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 3 months after Visit 1;
• Presence of significant endocrine diseases;
• Presence of active acute infectious diseases;
• Known narrow-angle glaucoma;
• Known epilepsy;
• Cimino-shunt operation on both arms;
• Pregnancy, intention thereof during study, lack of sufficient contraception, breastfeeding;
• Drug or alcohol abuse;

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Heart Center Zurich

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Interventions

Tramadol; Acetaminophen; Diclofenac

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Acetanilides; Anilides; Amides; Aniline Compounds; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Frank Ruschitzka, MD

  Cardiology, University Heart Center Zurich

  STUDY DIRECTOR

Central Study Contacts

Isabella Sudano, MD

CONTACT

+41442555841; Isabella.Sudano@usz.ch

Anne-Marieke Vegter

CONTACT

+41442552280; Anne-Marieke.Vegter@usz.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 20, 2018
• Study Start: January 1, 2019
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)