University of Health Sciences, Diyarbakir Gazi Yasargil Training and Research Hospital
Diyarbakır, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07587320
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Diyarbakır, Turkey (Türkiye)
Location status: Recruiting
Median sternotomy, chest drains, and saphenous vein graft harvesting are major contributors to postoperative pain following CABG surgery. Inadequate pain control may impair respiratory mechanics, delay mobilization, and increase postoperative morbidity. Multimodal analgesic approaches aim to reduce opioid requirements and improve recovery profiles.
This single-center, prospective, randomized controlled trial will include adult patients (18-80 years) scheduled for elective isolated CABG with saphenous vein graft harvesting. After written informed consent, eligible participants will be randomly assigned to either the intervention group or the control group.
The intervention group will receive ultrasound-guided bilateral superficial parasternal block, bilateral serratus anterior plane block, and adductor canal block following induction of general anesthesia and prior to surgical incision. The control group will receive standard perioperative analgesia without regional block. All other perioperative management will be standardized.
The primary endpoint is total opioid consumption within the first 24 hours postoperatively. Secondary endpoints include pain scores at predefined time points (6, 12, 24, and 48 hours), time to first opioid requirement, extubation time, incidence of postoperative pulmonary complications and atrial fibrillation, ICU length of stay, hospital length of stay, and time to first mobilization.
The study is designed to assess whether a multimodal fascial plane block strategy can improve postoperative analgesia and reduce opioid use in cardiac surgery patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants 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.
Participants will receive standard institutional perioperative and postoperative analgesia without regional fascial plane block.
Time frame: Through 48 hours after surgery
Total cumulative tramadol consumption (mg) during the first 48 hours following surgery.
Time frame: At 6, 12, 24, and 48 hours after surgery
Pain intensity measured using the Numeric Rating Scale (NRS; 0-10) at rest and during movement at predefined postoperative time points.
Time frame: Within 48 hours after surgery
Time from arrival to the intensive care unit to first rescue analgesic administration (hours).
Time frame: From ICU admission to extubation, assessed through 24 hours after surgery
Time from arrival to the intensive care unit to successful tracheal extubation (hours).
Contact information is provided by the study sponsor or research team.
Saglik Bilimleri Universitesi
Other
Effect of Induction-Time Multimodal Fascial Plane Block on Postoperative Analgesia and Opioid Consumption in Patients Undergoing Isolated Coronary Artery Bypass Grafting: A Prospective Randomized Controlled Trial
Acronym: BLOCKCABG
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)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.
Published trials that share one or more normalized conditions with this study.
NCT07287761
Coronary Artery Bypass Graft (CABG), Neurologic Manifestations
Ankara, Altındag, Turkey (Türkiye)
View Trial DetailsNCT07302659
Coronary Artery Bypass Graft (CABG)
Beijing, China
View Trial DetailsNCT06814587
Arterial Occlusive Diseases, Arteriosclerosis
Dallas, Texas, United States
View Trial DetailsNCT07116941
Anxiety Disorders, Cardiac Surgery Subjects
Bolu, Turkey (Türkiye)
View Trial Details