Multimodal Fascial Plane Block for Postoperative Analgesia in Isolated CABG Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSaglik Bilimleri Universitesi
About this trial
Postoperative pain following coronary artery bypass grafting (CABG) via median sternotomy remains a significant clinical problem and is associated with increased opioid consumption and postoperative complications. Fascial plane blocks have emerged as part of multimodal analgesia strategies in cardiac surgery.
This prospective, randomized, controlled, single-blinded study aims to evaluate the effect of an induction-time multimodal fascial plane block package-consisting of bilateral superficial parasternal block, bilateral serratus anterior plane block, and adductor canal block-on postoperative analgesia, opioid consumption, and clinical outcomes in patients undergoing elective isolated CABG with saphenous vein graft harvesting.
Patients will be randomized in a 1:1 ratio to receive either the multimodal fascial plane block package in addition to standard postoperative analgesia or standard postoperative analgesia alone. The primary outcome is total opioid consumption within the first 24 postoperative hours. Secondary outcomes include pain scores, time to first opioid requirement, extubation time, postoperative pulmonary complications, atrial fibrillation, and length of ICU and hospital stay.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 80 years
Scheduled for elective isolated coronary artery bypass grafting (CABG) with saphenous vein graft harvesting
ASA physical status II-IV
Ability to provide written informed consent
Disqualifiers
Known coagulopathy or contraindication to regional anesthesia
Use of anticoagulant therapy precluding regional block
Known allergy to local anesthetics
Local infection at planned block sites
Trial design
Design model
Parallel
Treatments tested in this trial
Multimodal Fascial Plane Block Package
Procedure/SurgeryParticipants will receive ultrasound-guided bilateral superficial parasternal block, bilateral serratus anterior plane block, and adductor canal block after induction of general anesthesia and before surgical incision.
Standard Postoperative Analgesia
Other interventionParticipants will receive standard institutional perioperative and postoperative analgesia without regional fascial plane block.
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Multimodal Fascial Plane Block GroupExperimental treatment 1 intervention
Group B: Standard Analgesia GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Total opioid consumption within the first 48 postoperative hours
Total cumulative tramadol consumption (mg) during the first 48 hours following surgery.
Time frame
Through 48 hours after surgerySecondary outcomes
1
Postoperative pain intensity scores
Pain intensity measured using the Numeric Rating Scale (NRS; 0-10) at rest and during movement at predefined postoperative time points.
Time frame
At 6, 12, 24, and 48 hours after surgery2
Time to first rescue analgesic requirement
Time from arrival to the intensive care unit to first rescue analgesic administration (hours).
Time frame
Within 48 hours after surgery3
Extubation time
Time from arrival to the intensive care unit to successful tracheal extubation (hours).
Time frame
From ICU admission to extubation, assessed through 24 hours after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Saglik Bilimleri Universitesi
Lead sponsor
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Sponsor institution
Source ClinicalTrials.gov