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Not yet recruiting NCT07716943

ASPB-PIPB Combination in Cardiac Surgery

No phase Interventional Postoperative Pain Cardiac Surgery Cardiopulmonary Bypass Median Sternotomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Combined ASPB and PIPB, Anterior Serratus Plane Block.
Who it may be relevant to
Registry conditions: Postoperative Pain, Cardiac Surgery, Cardiopulmonary Bypass, Median Sternotomy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Procedure Combined ASPB and PIPB
    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.
  • Procedure Anterior Serratus Plane Block
    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 outcome measures

  • Postoperative pain intensity [Time frame: At extubation (0 hour) and at 4, 8, 12, and 24 hours after surgery.]
Secondary outcome measures (10)
  • Intraoperative fentanyl consumption [Time frame: From induction of anesthesia until the end of surgery.]
  • Postoperative tramadol consumption [Time frame: During the first 24 hours after surgery.]
  • Time to extubation [Time frame: From the end of surgery until extubation, assessed up to 7 days after surgery.]
  • 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.]
  • Hospital length of stay [Time frame: From the date of surgery until hospital discharge, assessed up to 30 days after surgery.]
  • Incidence of postoperative cardiac arrhythmias [Time frame: From the end of surgery until hospital discharge, assessed up to 30 days after surgery.]
  • Incidence of block-related complications [Time frame: From block administration until hospital discharge, assessed up to 30 days after surgery.]
  • Incidence of postoperative surgical complications [Time frame: From the end of surgery until hospital discharge, assessed up to 30 days after surgery.]
  • 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 to urinary catheter removal [Time frame: From the end of surgery until urinary catheter removal, assessed up to 30 days after surgery.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Sisli etfal research and training hospital — Istanbul

Identifiers

NCT: NCT07716943 · 1025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗