- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07716943
ASPB-PIPB Combination in Cardiac Surgery
Effects of Combined Anterior Serratus Plane and Pectoral-Intercostal Plane Blocks on Perioperative Analgesia and Enhanced Recovery After Surgery in Cardiopulmonary Bypass Surgery
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: MUSTAFA ALTINAY
- Phone Number: 05333914422
- Email: m_altinay@yahoo.com
Study Locations
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-
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Istanbul, Turkey (Türkiye), 34371
- Sisli etfal research and training hospital
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Contact:
- MUSTAFA ALTINAY
- Phone Number: 05333914422
- Email: m_altinay@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: GroupASPB + PIPB Group
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.
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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.
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Active Comparator: ASPB Group:
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain intensity
Time Frame: At extubation (0 hour) and at 4, 8, 12, and 24 hours after surgery.
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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.
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At extubation (0 hour) and at 4, 8, 12, and 24 hours after surgery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraoperative fentanyl consumption
Time Frame: From induction of anesthesia until the end of surgery.
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Total dose of fentanyl administered from the induction of anesthesia until the end of surgery.
Fentanyl consumption will be recorded in micrograms.
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From induction of anesthesia until the end of surgery.
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Postoperative tramadol consumption
Time Frame: During the first 24 hours after surgery.
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Cumulative dose of tramadol administered for rescue analgesia during the first 24 hours after surgery.
Tramadol consumption will be recorded in milligrams.
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During the first 24 hours after surgery.
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Time to extubation
Time Frame: From the end of surgery until extubation, assessed up to 7 days after surgery.
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Time elapsed from the end of surgery until successful removal of the endotracheal tube.
Time to extubation will be recorded in hours.
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From the end of surgery until extubation, assessed up to 7 days after surgery.
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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.
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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.
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From postoperative intensive care unit admission until intensive care unit discharge, assessed up to 30 days after surgery.
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Hospital length of stay
Time Frame: From the date of surgery until hospital discharge, assessed up to 30 days after surgery.
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Time elapsed from the date of surgery until discharge from the hospital.
Hospital length of stay will be recorded in days.
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From the date of surgery until hospital discharge, assessed up to 30 days after surgery.
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Incidence of postoperative cardiac arrhythmias
Time Frame: From the end of surgery until hospital discharge, assessed up to 30 days after surgery.
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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.
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From the end of surgery until hospital discharge, assessed up to 30 days after surgery.
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Incidence of block-related complications
Time Frame: From block administration until hospital discharge, assessed up to 30 days after surgery.
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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.
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From block administration until hospital discharge, assessed up to 30 days after surgery.
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Incidence of postoperative surgical complications
Time Frame: From the end of surgery until hospital discharge, assessed up to 30 days after surgery.
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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.
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From the end of surgery until hospital discharge, assessed up to 30 days after surgery.
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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.
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Time elapsed from the end of surgery until removal of all thoracic drains.
Time to thoracic drain removal will be recorded in hours.
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From the end of surgery until removal of all thoracic drains, assessed up to 30 days after surgery.
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Time to urinary catheter removal
Time Frame: From the end of surgery until urinary catheter removal, assessed up to 30 days after surgery.
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Time elapsed from the end of surgery until removal of the urinary catheter.
Time to urinary catheter removal will be recorded in hours.
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From the end of surgery until urinary catheter removal, assessed up to 30 days after surgery.
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Collaborators and Investigators
Investigators
- Study Chair: LEYLA KILINC, şişli etfal eğitim araştırma hastanesi
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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