NCT04916418CompletedPhase 4
Postoperative Pain Relief With Transversus Thoracis Muscle Plane Block After Cardiac Surgery
Ultrasound Guided Repeated Bilateral Transversus Thoracis Muscle Plane Block Via Catheter and Postoperative Pain in Cardiac Surgery
Source: ClinicalTrials.gov · Last updated 13 Apr 2025
Brief summary (registry, in English)
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 elective cardiac surgery with sternotomy.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (actual)
- First submitted
- 27 May 2021
- Start date
- 15 Oct 2021
- Primary completion date
- 1 Dec 2023
- Lead sponsor
- Turku University Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT04916418
- EudraCT number
- 2020-004178-23
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 120
- From 15 Oct 2021 to the primary completion date, 1 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A previous history of intolerance to the study drug or related compounds and additives
- Redo surgery
- Concomitant drug therapy with strong opioids or strong CYP3A4 or CYP2D6 inductor(s) or inhibitor(s) 2 weeks prior to study.
- BMI \> 35, sleep apnoea, any other sleep disorder or condition that requires treatment with continuous positive airway pressure or automatic positive airway pressure device.
- 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
Other illness
- Combined CABG and heart valve surgery
- 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.
- Patients with a diagnosis for neuropathic pain or chronic pain syndrome
- Insulin dependent diabetes mellitus with neuropathy
Lab values
- Diagnosed hepatic cirrhosis or kidney disease: GFR \< 29 ml/min/1,73 m2 or dependence on dialysis
- Cardiac insufficiency, ejection fraction (LVEF) \< 30 %
Age
- Patients younger than 18 years or older than 80 years.
Other
- Endocarditis and/or mediastinitis.
- Body weight \< 60 kg
- Pregnancy or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital and University of Turku Coordinator of this site? Confirm its status | Turku | Finland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.