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De effecten van een rechter paravertebraal blok op de werking van het hart bij patiënten met pulmonale hypertentie die minimaal invasieve mitralisklepchirugie ondergaan.

The effects of right paravertebral blockade on biventricular performance in patients with chronic pulmonary hypertension scheduled for minimally invasive mirtral valve surgery.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-002000-14-BE
Enrollment
Unknown
Registered
2013-06-12
Start date
2013-07-17
Completion date
Unknown
Last updated
2014-08-11

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

Conditions

patients with pulmonary hypertension scheduled for elective minimally invasive mitral valve surgery using heartport technique.

Interventions

Trade Name: Chirocaine Product Name: Chirocaine Pharmaceutical Form: Solution for injection INN or Proposed INN: levobupivacaine CAS Number: 27262-48-2 Other descriptive name: LEVOBUPIVACAINE HYDROCHL

Sponsors

University Hospitals Leuven
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - patient scheduled for minimal invasive mitral valve surgery via right thoracotomy - ASA II - IV - chronic pulmonary hypertensio (systolic PAP >50 mmHg) 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: - previous cardiac surgery -contra-indication for TEE - contra-indication for paravertebral block (allergies to local anesthetics, local infection, coagulation disorder, systemic inflammation,...) - Tricupid insufficiency > 1/4 - patient refusal

Design outcomes

Primary

MeasureTime frame
Main Objective: a right paravertebral block does not influence the baseline myocardial performance of both the right and left ventricle in patients with chronically increase right ventricular afterload.;Secondary Objective: A right paravertebral block inhibits the positive inotropic response of the right ventricular to an acute increase in right ventricular afterload;Primary end point(s): Right ventricular function;Timepoint(s) of evaluation of this end point: after insertion of the paravertebral catheter after onset of unilateral sympathetic blockade after 20 min of single lung ventilation

Secondary

MeasureTime frame
Secondary end point(s): no secondary endpoint;Timepoint(s) of evaluation of this end point: not applicable

Countries

Belgium

Contacts

Public ContactResearch Anesthesiology

University Hospitals Leuven

christel.huygens@uzleuven.be+3216344270

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026