Status:
COMPLETED
Postoperative Pain Relief With Transversus Thoracis Muscle Plane Block After Cardiac Surgery
Lead Sponsor:
Turku University Hospital
Conditions:
Pain, Postoperative
Anesthesia, Local
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
This study aims to investigate the effect of transversus thoracis muscle plane block (TTP), using repeated boluses of ropivacaine via catheter, on postoperative pain and oxycodone consumption after el...
Detailed Description
This randomized, double-blinded, controlled study aims to investigate the effect of transversus thoracis muscle plane block (TTP), using repeated boluses of ropivacaine via catheter, on postoperative ...
Eligibility Criteria
Inclusion
- 18 - 80 years of age
- The patient is scheduled for open cardiac coronary arterial bypass graft (CABG) OR single heart valve surgery that require median sternotomy under general anesthesia
- Patients that are estimated to be weaned from mechanical ventilator not later than 8 h after surgery
- Patients that are capable of using the patient controlled analgesia device (PCA) after surgery
- Written informed consent from the patient
Exclusion
- A previous history of intolerance to the study drug or related compounds and additives
- Redo surgery
- Combined CABG and heart valve surgery
- Endocarditis and/or mediastinitis.
- Concomitant drug therapy with strong opioids or strong CYP3A4 or CYP2D6 inductor(s) or inhibitor(s) 2 weeks prior to study.
- Patients younger than 18 years or older than 80 years.
- Body weight \< 60 kg
- BMI \> 35, sleep apnoea, any other sleep disorder or condition that requires treatment with continuous positive airway pressure or automatic positive airway pressure device.
- Diagnosed hepatic cirrhosis or kidney disease: GFR \< 29 ml/min/1,73 m2 or dependence on dialysis
- History of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent. If the researcher judge, that the patient has a mental health disorder, retardation or other similar reason and do not have the capacity to give his/her consent to research or patient do not understand the meaning of the study, or is not able to use PCA device, the patient is to be exluded. History of alcoholism or drug abuse (especially opioid) may affect the use of opioid PCA device and make harm to the patient or invalid the study and are exluded.
- Cardiac insufficiency, ejection fraction (LVEF) \< 30 %
- Patients with a diagnosis for neuropathic pain or chronic pain syndrome
- Insulin dependent diabetes mellitus with neuropathy
- Participation in any other study concomitantly or within one month prior to the entry into this study
- Donation of blood for 4 weeks prior and during the study
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
October 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04916418
Start Date
October 15 2021
End Date
January 31 2025
Last Update
April 13 2025
Active Locations (1)
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1
Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital and University of Turku
Turku, Finland