Multimodal Fascial Plane Block for Postoperative Analgesia in Isolated CABG Surgery (BLOCKCABG)
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
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Diyarbakır
-
Diyarbakır, Diyarbakır, Turkiet (Türkiye)
- University of Health Sciences, Diyarbakir Gazi Yasargil Training and Research Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Chronic opioid use or chronic pain syndrome
- Emergency surgery
- Redo sternotomy
- Severe neurological disorder affecting pain assessment
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Multimodal Fascial Plane Block Group
Participants will receive a multimodal fascial plane block package consisting of bilateral superficial parasternal block, bilateral serratus anterior plane block, and adductor canal block following induction of general anesthesia and before surgical incision, in addition to standard perioperative analgesia. |
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. |
|
Aktiv komparator: Standard Analgesia Group
Participants will receive standard perioperative and postoperative analgesia without regional fascial plane block intervention. |
Participants will receive standard institutional perioperative and postoperative analgesia without regional fascial plane block. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Total opioid consumption within the first 48 postoperative hours
Tidsram: Through 48 hours after surgery
|
Total cumulative tramadol consumption (mg) during the first 48 hours following surgery. |
Through 48 hours after surgery
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postoperative pain intensity scores
Tidsram: 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. |
At 6, 12, 24, and 48 hours after surgery
|
|
Time to first rescue analgesic requirement
Tidsram: Within 48 hours after surgery
|
Time from arrival to the intensive care unit to first rescue analgesic administration (hours). |
Within 48 hours after surgery
|
|
Extubation time
Tidsram: From ICU admission to extubation, assessed through 24 hours after surgery
|
Time from arrival to the intensive care unit to successful tracheal extubation (hours). |
From ICU admission to extubation, assessed through 24 hours after surgery
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Selen Topalel, MD, University of Health Sciences, Diyarbakir Gazi Yasargil Training and Research Hospital
Publikationer och användbara länkar
Allmänna publikationer
- Zengin EN, Yigit H, Cobas M, Salman N, Asli Demir Z. The analgesic effects of combined bilateral parasternal block and serratus anterior plane block for coronary artery bypass grafting surgery. BMC Anesthesiol. 2024 Aug 5;24(1):274. doi: 10.1186/s12871-024-02659-7.
- Kalli A, Vistbacka J, Moilanen E, Jarvela K, Mennander A. Superficial Parasternal Intercostal Plane Block and Full Sternotomy; A Randomized Trial. Eur J Cardiothorac Surg. 2025 Jul 1;67(7):ezaf226. doi: 10.1093/ejcts/ezaf226.
- Zhang J, Luo F, Zhang X, Xue Y. Ultrasound-Guided Continuous Parasternal Intercostal Block Relieves Postoperative Pain After Open Cardiac Surgery: A Case Series. J Cardiothorac Vasc Anesth. 2022 Jul;36(7):2051-2054. doi: 10.1053/j.jvca.2021.05.028. Epub 2021 May 21.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- GY-CABG-2026
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Individual participant data will not be publicly shared due to institutional and privacy restrictions.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .