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NCT Number: NCT07716943

ASPB-PIPB Combination in Cardiac Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sisli etfal research and training hospital

Istanbul, 34371, Turkey (Türkiye)

Location contact

MUSTAFA ALTINAY

CONTACT

[email protected]

05333914422

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing open heart surgery via median sternotomy by the Cardiovascular Surgery Clinic
  • Patients over 18 years of age
  • ASA II-III patients

Exclusion criteria

  • - Patients undergoing emergency or recurrent surgery
  • Patients with left ventricular ejection fraction < 30
  • Patients who died per-operatively
  • Patients who do not provide informed consent
  • Presence of chronic pain
  • Presence of allergy to local anesthetics
  • Presence of infection in the area where the block will be performed
  • Coagulopathy
  • Pre-existing neurological deficit
  • Mental retardation
  • Anatomical deformity

Treatment and study plan

Combined ASPB and PIPB

Procedure

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.

Anterior Serratus Plane Block

Procedure

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.

Primary outcomes

  1. Postoperative pain intensity

    Time frame: At extubation (0 hour) and at 4, 8, 12, and 24 hours after surgery.

    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.

Secondary outcomes

  1. Intraoperative fentanyl consumption

    Time frame: From induction of anesthesia until the end of surgery.

    Total dose of fentanyl administered from the induction of anesthesia until the end of surgery. Fentanyl consumption will be recorded in micrograms.

  2. Postoperative tramadol consumption

    Time frame: During the first 24 hours after surgery.

    Cumulative dose of tramadol administered for rescue analgesia during the first 24 hours after surgery. Tramadol consumption will be recorded in milligrams.

  3. Time to extubation

    Time frame: From the end of surgery until extubation, assessed up to 7 days after surgery.

    Time elapsed from the end of surgery until successful removal of the endotracheal tube. Time to extubation will be recorded in hours.

  4. Intensive care unit length of stay

    Time frame: From postoperative intensive care unit admission until intensive care unit discharge, assessed up to 30 days after surgery.

    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.

  5. Hospital length of stay

    Time frame: From the date of surgery until hospital discharge, assessed up to 30 days after surgery.

    Time elapsed from the date of surgery until discharge from the hospital. Hospital length of stay will be recorded in days.

  6. Incidence of postoperative cardiac arrhythmias

    Time frame: From the end of surgery until hospital discharge, assessed up to 30 days after surgery.

    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.

  7. Incidence of block-related complications

    Time frame: From block administration until hospital discharge, assessed up to 30 days after surgery.

    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.

  8. Incidence of postoperative surgical complications

    Time frame: From the end of surgery until hospital discharge, assessed up to 30 days after surgery.

    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.

  9. Time to thoracic drain removal

    Time frame: From the end of surgery until removal of all thoracic drains, assessed up to 30 days after surgery.

    Time elapsed from the end of surgery until removal of all thoracic drains. Time to thoracic drain removal will be recorded in hours.

  10. Time to urinary catheter removal

    Time frame: From the end of surgery until urinary catheter removal, assessed up to 30 days after surgery.

    Time elapsed from the end of surgery until removal of the urinary catheter. Time to urinary catheter removal will be recorded in hours.

Study contacts

Contact information is provided by the study sponsor or research team.

MUSTAFA ALTINAY

CONTACT

[email protected]

05333914422

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Official study title

Effects of Combined Anterior Serratus Plane and Pectoral-Intercostal Plane Blocks on Perioperative Analgesia and Enhanced Recovery After Surgery in Cardiopulmonary Bypass Surgery

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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