An interventional study of Combined ASPB and PIPB and Anterior Serratus Plane Block in Postoperative Pain, Cardiac Surgery and Cardiopulmonary Bypass, sponsored by Sisli Hamidiye Etfal Training and Research Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Sisli Hamidiye Etfal Training and Research Hospital · Not applicable, Interventional, and Treatment
Cardiopulmonary bypass surgery is associated with significant postoperative pain, which may adversely affect respiratory function, delay mobilization, prolong hospital stay, and increase postoperative complications. Within Enhanced Recovery After Surgery (ERAS) protocols, multimodal analgesia and opioid-sparing strategies have become essential components of perioperative care. Ultrasound-guided fascial plane blocks, including the anterior serratus plane block (ASPB) and pectoral-intercostal plane block (PIPB), have emerged as effective and safe regional anesthesia techniques for cardiac surgery, targeting different sensory innervation of the thoracic wall. However, evidence regarding the combined use of these two blocks remains limited. This study aimed to evaluate whether the combination of ASPB and PIPB improves intraoperative and postoperative analgesia, reduces opioid consumption, and enhances postoperative recovery and ERAS outcomes compared with standard analgesic management in patients undergoing cardiopulmonary bypass surgery.
Cardiac surgery performed with cardiopulmonary bypass (CPB) is associated with substantial perioperative nociceptive stimulation originating from median sternotomy, chest tube placement, internal mammary artery harvesting, and extensive mediastinal tissue manipulation. Despite advances in surgical techniques and perioperative care, postoperative pain remains a major challenge following cardiac surgery. Inadequately controlled pain contributes to impaired respiratory mechanics, ineffective coughing, reduced pulmonary function, delayed mobilization, prolonged intensive care unit (ICU) and hospital stay, and an increased incidence of postoperative pulmonary complications. Furthermore, excessive perioperative opioid administration may lead to respiratory depression, postoperative nausea and vomiting, ileus, delirium, and delayed recovery, highlighting the need for effective opioid-sparing analgesic strategies.
Enhanced Recovery After Surgery (ERAS) protocols have increasingly been adopted in cardiac surgery with the aim of reducing perioperative stress, minimizing complications, and accelerating functional recovery. Contemporary ERAS guidelines emphasize multimodal analgesia as a cornerstone of perioperative management, integrating regional anesthesia techniques with non-opioid systemic analgesics to reduce opioid consumption while improving pain control. Ultrasound-guided fascial plane blocks have gained considerable popularity because they are technically straightforward, provide effective thoracic analgesia, and have a favorable safety profile compared with neuraxial techniques in anticoagulated cardiac surgical patients. Among these techniques, the anterior serratus plane block (ASPB) effectively anesthetizes the lateral thoracic wall by blocking the lateral cutaneous branches of the intercostal nerves, whereas the pectoral-intercostal plane block (PIPB) primarily targets the anterior cutaneous branches responsible for pain arising from median sternotomy. Given their complementary anatomical distributions, combining ASPB and PIPB may provide more comprehensive analgesic coverage of both the anterior and lateral thoracic walls.
Although both ASPB and PIPB have individually demonstrated promising analgesic efficacy in cardiac surgery, evidence regarding the combined use of these two fascial plane blocks remains limited. Whether the addition of ASPB to PIPB results in superior perioperative analgesia, reduced opioid requirements, improved postoperative recovery, and enhanced compliance with ERAS pathways has not yet been clearly established. Therefore, the present study aimed to compare the effects of combined anterior serratus plane block and pectoral-intercostal plane block with standard analgesic management on intraoperative opioid consumption, postoperative pain scores, postoperative analgesic requirements, recovery parameters, and ERAS-related outcomes in patients undergoing cardiopulmonary bypass surgery.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 60 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Sisli Hamidiye Etfal Training and Research Hospital is the lead sponsor of 114 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this group received ultrasound-guided bilateral anterior serratus plane block combined with bilateral pectoral-intercostal plane block after induction of general anesthesia and before surgical incision as part of the multimodal analgesia protocol.
Procedure: Combined ASPB and PIPB
Patients assigned to the ASPB group underwent ultrasound-guided bilateral anterior serratus plane block following induction of general anesthesia and prior to skin incision. The block was incorporated into the perioperative multimodal analgesia protocol.
Procedure: Anterior Serratus Plane Block
Ultrasound-guided bilateral anterior serratus plane block combined with bilateral pectoral-intercostal plane block performed after induction of general anesthesia and before surgical incision to provide perioperative multimodal analgesia in patients undergoing cardiopulmonary bypass surgery.
Ultrasound-guided bilateral anterior serratus plane block performed after induction of general anesthesia and before surgical incision to provide perioperative analgesia in patients undergoing cardiopulmonary bypass surgery.
Postoperative pain intensity
Postoperative pain intensity will be assessed at rest and during coughing using the Visual Analog Scale at extubation (0 hour) and at 4, 8, 12, and 24 hours after surgery. The Visual Analog Scale ranges from 0 to 10 cm, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
Time frame: At extubation (0 hour) and at 4, 8, 12, and 24 hours after surgery.
Intraoperative fentanyl consumption
Total dose of fentanyl administered from the induction of anesthesia until the end of surgery. Fentanyl consumption will be recorded in micrograms.
Time frame: From induction of anesthesia until the end of surgery.
Postoperative tramadol consumption
Cumulative dose of tramadol administered for rescue analgesia during the first 24 hours after surgery. Tramadol consumption will be recorded in milligrams.
Time frame: During the first 24 hours after surgery.
Time to extubation
Time elapsed from the end of surgery until successful removal of the endotracheal tube. Time to extubation will be recorded in hours.
Time frame: From the end of surgery until extubation, assessed up to 7 days after surgery.
Intensive care unit length of stay
Time elapsed from postoperative admission to the intensive care unit until discharge from the intensive care unit. Length of stay will be recorded in days.
Time frame: From postoperative intensive care unit admission until intensive care unit discharge, assessed up to 30 days after surgery.
Hospital length of stay
Time elapsed from the date of surgery until discharge from the hospital. Hospital length of stay will be recorded in days.
Time frame: From the date of surgery until hospital discharge, assessed up to 30 days after surgery.
Incidence of postoperative cardiac arrhythmias
Number of participants who develop a new postoperative cardiac arrhythmia documented by electrocardiography or continuous cardiac monitoring during the index hospitalization. Results will be reported as the number and percentage of participants with at least one cardiac arrhythmia.
Time frame: From the end of surgery until hospital discharge, assessed up to 30 days after surgery.
Incidence of block-related complications
Number of participants who develop at least one complication related to the regional anesthesia procedure, including local anesthetic systemic toxicity, vascular puncture, hematoma, infection, pneumothorax, or nerve injury. Results will be reported as the number and percentage of participants with at least one block-related complication.
Time frame: From block administration until hospital discharge, assessed up to 30 days after surgery.
Incidence of postoperative surgical complications
Number of participants who develop at least one postoperative surgical complication during the index hospitalization. Results will be reported as the number and percentage of participants with at least one surgical complication.
Time frame: From the end of surgery until hospital discharge, assessed up to 30 days after surgery.
Time to thoracic drain removal
Time elapsed from the end of surgery until removal of all thoracic drains. Time to thoracic drain removal will be recorded in hours.
Time frame: From the end of surgery until removal of all thoracic drains, assessed up to 30 days after surgery.
Time to urinary catheter removal
Time elapsed from the end of surgery until removal of the urinary catheter. Time to urinary catheter removal will be recorded in hours.
Time frame: From the end of surgery until urinary catheter removal, assessed up to 30 days after surgery.
Plan to share: No
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