About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Thoracic paravertebral block (TPVB)
Procedure/SurgeryUltrasound-guided thoracic paravertebral block performed before elective cardiac surgery via median sternotomy, in addition to standard general anesthesia and routine multimodal analgesia.
Bilateral Deep Parasternal Intercostal Plane Block
Procedure/SurgeryUltrasound-guided bilateral deep parasternal intercostal plane block performed before elective cardiac surgery via median sternotomy, in addition to standard general anesthesia and routine multimodal analgesia.
Treatment groups
Trial outcomes
Primary outcomes
Total Opioid Consumption in the First 24 Hours After Surgery
Total opioid consumption during the first 24 postoperative hours will be recorded and compared between the two groups.
Secondary outcomes
Postoperative Pain Scores Assessed by Visual Analog Scale
Postoperative pain intensity will be assessed using the Visual Analog Scale at predefined postoperative time points and compared between groups.
Additional Analgesic Requirement
The need for rescue or additional analgesic medication during the first 24 postoperative hours will be recorded and compared between groups.
Analgesia-Related Adverse Effects
Analgesia-related adverse effects, including nausea, vomiting, and respiratory depression, will be recorded and compared between groups.
Extubation Time
Time from the end of surgery to extubation will be recorded and compared between groups.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: