Erector Spinae plane block for minimal invasive mitral valve surgery. A double blind, prospective randomized placebo-controlled trial.

Phase 1

• Conditions: postoperative pain; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2019-001125-27-BE
• Lead Sponsor: niversity Hospitals Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-29
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

18-75 years of age
BMI <= 35
Euroscore <= 3
Patient is scheduled for elective mitral valve surgery
patient enrolled in the fast-track program
patient is able to provide written informed consent
patient understands the use of morphine IV PCA
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 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 27

Exclusion Criteria

Patient refusal
inability to operate a PCA system
planned admission to Intensice Care Unit
Chronic opioid use
Obstructive sleep apnea syndrome
epilepsy

Study & Design

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