ASPB-PIPB Combination in Cardiac Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSisli Hamidiye Etfal Training and Research Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing open heart surgery via median sternotomy by the Cardiovascular Surgery Clinic
Patients over 18 years of age
ASA II-III patients
Disqualifiers
- 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
Trial design
Design model
Parallel
Treatments tested in this trial
Combined ASPB and PIPB
Procedure/SurgeryUltrasound-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/SurgeryUltrasound-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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: GroupASPB + PIPB GroupExperimental treatment 1 intervention
Group B: ASPB Group:Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
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Source ClinicalTrials.gov
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