Comparison of Paravertebral Block and Deep Parasternal Intercostal Plane Block in Cardiac Surgery (NCT07498946) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparison of Paravertebral Block and Deep Parasternal Intercostal Plane Block in Cardiac Surgery
Turkey (Türkiye)80 participantsStarted 2026-04-18
Plain-language summary
Median sternotomy is commonly used in cardiac surgery and is often associated with significant postoperative pain. Poor pain control after sternotomy may increase opioid use, delay mobilization, prolong extubation time, and contribute to respiratory complications and longer hospital stay. Regional analgesia techniques may help improve pain management and reduce opioid requirements after surgery.
This study is a prospective, randomized, single-center clinical trial that will compare two ultrasound-guided regional analgesia techniques in adult patients undergoing elective cardiac surgery through median sternotomy: thoracic paravertebral block and bilateral deep parasternal intercostal plane block. A total of 80 patients will be randomly assigned in a 1:1 ratio to receive one of these two blocks in addition to standard general anesthesia and routine multimodal analgesia.
The main objective of the study is to compare the effects of these two techniques on total opioid consumption during the first 24 hours after surgery. Secondary outcomes include postoperative pain scores, need for additional analgesics, analgesia-related side effects such as nausea, vomiting, or respiratory depression, and extubation time. Pain will be assessed using a visual analog scale at predefined time points during the first 24 postoperative hours.
The study hypothesis is that there will be a clinically meaningful difference in postoperative analgesic effectiveness between thoracic paravertebral block and bilateral deep parasternal intercostal plane block in patients undergoing cardiac surgery via median sternotomy. The results of this study may help guide the selection of the most appropriate regional analgesia technique for pain control after sternotomy.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Age 18 to 65 years Scheduled for elective cardiac surgery via median sternotomy American Society of Anesthesiologists physical status II or III Planned to undergo surgery under general anesthesia Able to comply with postoperative pain assessment using the Visual Analog Scale Able to provide written informed consent
Exclusion Criteria:
Emergency cardiac surgery Cardiac surgery performed through an approach other than median sternotomy Redo sternotomy Local infection or skin disruption at the planned block site Known allergy or hypersensitivity to amide local anesthetics Clinically significant coagulopathy or antiplatelet/anticoagulant treatment preventing safe regional block according to institutional protocol Clinically unstable condition or high risk for pleural complications that would make the block unsafe Chronic opioid use or chronic pain syndrome Advanced musculoskeletal disease or deformity that may interfere with pain assessment Neurological or psychiatric disorder causing inability to comply with postoperative pain assessment Cognitive impairment preventing reliable pain assessment Clinically significant peripheral neuropathy or other neurosensory condition affecting pain perception Pregnancy or breastfeeding Severe pulmonary disease, including advanced chronic obstructive pulmonary disease or severe restrictive lung disease Anticipated inability to comply with the study protocol
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Opioid Consumption in the First 24 Hours After Surgery