Erector Spinae Plane Block and Postoperative Recovery After Open-Heart Surgery (NCT07259057) | Clinical Trial Compass
CompletedNot Applicable
Erector Spinae Plane Block and Postoperative Recovery After Open-Heart Surgery
Turkey (Türkiye)66 participantsStarted 2023-01-30
Plain-language summary
This prospective randomized controlled clinical trial evaluated the effects of bilateral erector spinae plane block (ESPB) on postoperative systemic functions in adult patients undergoing elective open-heart surgery via median sternotomy. Sixty-six participants were randomized to receive either bilateral ultrasound-guided ESPB before anesthesia induction or standard intravenous opioid analgesia. Postoperative outcomes-including pain scores, rescue analgesic requirements, hemodynamic parameters, respiratory variables, and laboratory values-were monitored for forty-eight hours. The study was conducted to determine whether ESPB provides improved postoperative pain control and supports systemic recovery compared with intravenous opioid-based analgesia.
Who can participate
Age range
18 Years – 85 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:
* Adults aged 18 to 75 years
* Scheduled for elective open-heart surgery via median sternotomy (CABG or valve surgery)
* ASA physical status II-III
* Provided written informed consent
* BMI \< 35 kg/m²
Exclusion Criteria:
* Age \<18 or \>75 years
* Known coagulopathy or anticoagulation contraindicating regional block
* Infection or dermatological lesion at the injection site
* Allergy to local anesthetics
* Chronic use of opioids, anticonvulsants, antidepressants, or corticosteroids
* Significant psychiatric or cognitive disorder preventing cooperation
* Severe arrhythmia or hemodynamic instability prior to surgery
* Local anesthetic toxicity risk factors or anatomic deformity preventing block placement
* Non-elective or emergency cardiac surgery
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
Postoperative Pain Intensity (NRS Score)
Timeframe: First 12 hours after extubation (measured at 1, 6, and 12 hours)