cardiac disease necessitating surgery with sternotomy MedDRA version: 20.0 Level: LLT Classification code 10046972 Term: Valvular heart disease NOS System Organ Class: 100000004849 MedDRA version: 20.0 Level: LLT Classification code 10055218 Term: Ischemic heart disease System Organ Class: 100000004849
Conditions
Interventions
Trade Name: Oxycodone Orion
Product Name: Oxycodone Orion
Pharmaceutical Form: Injection
Trade Name: Ropivacain Fresenius Kabi
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Inje
Sponsors
Turku University Hospital
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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 11. Cardiac insufficiency, ejection fraction (LVEF) < 30 % 12. Patients with a diagnosis for neuropathic pain or chronic pain syndrome 13. Insulin dependent diabetes mellitus with neuropathy 14. Participating in other clinical trial under TTP study 15. Donation of blood for 4 weeks prior and during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of transversus thoracis muscle plane block (TTP) on pain ratings, using repeated boluses of ropivacaine via catheter, on postoperative pain and oxycodone consumption after elective cardiac surgery with sternotomy. ;Secondary Objective: To investigate the effect of transversus thoracis muscle plane block (TTP) on reduction in oxycodone consumption, on sensations that are considered to be caused by systemic toxicity of ropivacaine, and on the length of ICU and hospital stay ;Primary end point(s): Pain scores (NRS) at rest and on movement ;Timepoint(s) of evaluation of this end point: 24, 48, 72 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Reduction in oxycodone consumption -Any sensation that is considered to be caused by systemic toxicity of ropivacaine -Length of ICU and hospital stay ;Timepoint(s) of evaluation of this end point: 24, 48 and 72 hours postoperatively | — |
Countries
Finland
Contacts
Public ContactTYKS
Turku University Hospital
Outcome results
None listed