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Clinical Trials/EUCTR2020-004178-23-FI
EUCTR2020-004178-23-FI
Active, not recruiting
Phase 1

ltrasound Guided Repeated Bilateral Transversus Thoracis Muscle Plane Block (TTP) via catheter and postoperative pain in Cardiac Surgery - TTPcat

Turku University Hospital0 sites120 target enrollmentFebruary 10, 2021

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
cardiac disease necessitating surgery with sternotomy
Sponsor
Turku University Hospital
Enrollment
120
Status
Active, not recruiting
Last Updated
5 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 10, 2021
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\.18 \- 80 years of age
  • 2\.Scheduled for open cardiac coronary arterial bypass graft (CABG) OR single heart valve surgery that require median sternotomy under general anesthesia
  • 3\.Patients that are estimated to be weaned from mechanical ventilator not later than 8 h after surgery
  • 4\.Patients that are capable of using the patient controlled analgesia device (PCA) after surgery
  • 5\.Written informed consent
  • 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 120
  • F.1\.3 Elderly (\>\=65 years) no

Exclusion Criteria

  • 1\.A previous history of intolerance to the study drug or related compounds and additives
  • 2\.Redo surgery
  • 3\.Combined CABG and heart valve surgery
  • 4\.Endocarditis and/or mediastinitis
  • 5\.Concomitant drug therapy with strong opioids or strong CYP3A4 or CYP2D6 inductor(s) or inhibitor(s) 2 weeks prior to study.
  • 6\.Patients younger than 20 years or older than 80 years.
  • 7\.Body weight \< 60 kg
  • 8\.BMI \> 35, sleep apnoea, any other sleep disorder or condition that requires treatment with continuous positive airway pressure or automatic positive airway pressure device.
  • 9\.Existing significant liver or kidney disease
  • 10\.History of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent

Outcomes

Primary Outcomes

Not specified

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