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New treatment option for Postoperative Pain
Official title The Effect of Superficial Parasternal Intercostal Plane Block on Pulmonary Function Tests After Cardiac Surgery
ClinicalTrials.gov ID: NCT05999721
What this study is testing
- What it's testing
- In adult patients undergoing cardiac surgery, does adding an sPIP block to standard care compared to standard care alone result in a smaller decrease in PFTs?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients who are scheduled to undergo elective cardiac surgery via sternotomy (i.e., coronary artery bypass graft, valvular surgery, and combined...
- Body Mass Index (BMI) above 20 and below 40 kg m-2
- Age above 18 years.
- Eligible to sign informed consent.
You likely can't join if
- Emergency surgery.
- Redo surgery.
- Off-pump surgeries.
- Pregnancy.
- Preoperative mechanical circulatory support (i.e., intra-aortic balloon pump, extracorporeal membrane oxygenation, ventricular assist devices).
- Preoperative chronic pain (i.e., fibromyalgia, chronic neuropathic pain).
See the full eligibility criteria
- Patients who are scheduled to undergo elective cardiac surgery via sternotomy (i.e., coronary artery bypass graft, valvular surgery, and combined surgery).
- Body Mass Index (BMI) above 20 and below 40 kg m-2
- Age above 18 years.
- Eligible to sign informed consent.
- Emergency surgery.
- Redo surgery.
- Off-pump surgeries.
- Pregnancy.
- Preoperative mechanical circulatory support (i.e., intra-aortic balloon pump, extracorporeal membrane oxygenation, ventricular assist devices).
- Preoperative chronic pain (i.e., fibromyalgia, chronic neuropathic pain).
- Contraindication for regional analgesia (i.e., known allergy to LA, skin lesions in the injection site).
- Known allergy to one or more of the components of multimodal analgesia (i.e., opioids, paracetamol, tramadol, dipyrone).
- Preexisting severe pulmonary disease (i.e., an obstructive lung disease with FEV1 below 49%, restrictive lung disease with FVC below 49%, pulmonary hypertension). Criteria For Discontinuing (Postoperative Exclusion...
- Prolonged cardiopulmonary bypass (CPB) of more than three hours.
- Transfusion of more than three units of blood products.
- Severe coagulation disturbance requiring prothrombin complex concentrate or recombinant factor VII.
- Left ventricular failure with vasoactive-inotropic score (VIS) at the end of the surgery of ≥ 20.
- Right ventricular failure requires inhaled nitric oxide.
- Need for mechanical circulatory support (i.e., intra-aortic balloon pump, extracorporeal membrane oxygenation).
- Patients requiring mechanical ventilation for more than 24 hours postoperatively.
The study team makes the final eligibility decision.
Where it's taking place
- Petah Tikva, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Petah Tikva, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.