Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Multimodal Fascial Plane Block for Postoperative Analgesia in Isolated CABG Surgery (BLOCKCABG)

12. maj 2026 opdateret af: Selen Topalel, Saglik Bilimleri Universitesi

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

56

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Tyrkiet (Türkiye)
    • Diyarbakır
      • Diyarbakır, Diyarbakır, Tyrkiet (Türkiye)
        • Rekruttering
        • University of Health Sciences, Diyarbakir Gazi Yasargil Training and Research Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Procedure: Multimodal Fascial Plane Block Package
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.
Andet: Standard Postoperative Analgesia
Participants will receive standard institutional perioperative and postoperative analgesia without regional fascial plane block.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total opioid consumption within the first 48 postoperative hours
Tidsramme: Through 48 hours after surgery
Total cumulative tramadol consumption (mg) during the first 48 hours following surgery.
Through 48 hours after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative pain intensity scores
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Saglik Bilimleri Universitesi

Efterforskere

  • Ledende efterforsker: Selen Topalel, MD, University of Health Sciences, Diyarbakir Gazi Yasargil Training and Research Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2026

Primær færdiggørelse (Anslået)

1. august 2026

Studieafslutning (Anslået)

1. september 2026

Datoer for studieregistrering

Først indsendt

14. februar 2026

Først indsendt, der opfyldte QC-kriterier

12. maj 2026

Først opslået (Faktiske)

14. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GY-CABG-2026

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be publicly shared due to institutional and privacy restrictions.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Postoperativ smerte

Kliniske forsøg med Multimodal Fascial Plane Block Package

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Greece

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner