Serratus Anterior Plan Block (SAP) og Pectoralis Blocks (PECS I-II) efter åben hjertekirurgi
Serratus Anterior Plan Block (SAP) og Pectoralis Blocks (PECS I-II) -applikation efter åben hjerteoperation
This prospective randomized placebo-controlled trial was designed to evaluate the effects of ultrasound-guided bilateral pectoralis (PECS II) and serratus anterior plane (SAP) blocks on postoperative recovery in adult patients undergoing elective coronary artery bypass grafting (CABG). Patients were randomized to receive bilateral PECS II block, bilateral SAP block, or bilateral sham fascial plane injections in addition to standardized systemic analgesia. The study evaluated postoperative pain intensity using the Visual Analog Scale (VAS), opioid consumption, postoperative nausea and vomiting (PONV), block-related complications, duration of mechanical ventilation, time to first mobilization, and intensive care unit (ICU) length of stay.
Studieoversigt
Status
Detaljeret beskrivelse
This prospective, randomized, placebo-controlled trial evaluated the postoperative analgesic efficacy of ultrasound-guided bilateral serratus anterior plane (SAP) block and bilateral PECS II block in adult patients undergoing elective coronary artery bypass grafting (CABG). Participants were randomly assigned to one of three groups: bilateral SAP block, bilateral PECS II block, or bilateral sham fascial plane injections (placebo comparator). All participants received the same standardized postoperative systemic analgesic regimen.
To preserve allocation concealment and blinding, an investigator not involved in patient management prepared identical coded syringes according to the randomization sequence. The physician performing the ultrasound-guided procedures was unaware of syringe contents. All participants underwent bilateral injections at both the PECS II and SAP fascial planes; depending on group allocation, each fascial plane received either 0.25% bupivacaine or 0.9% saline. Postoperative outcome assessment was performed by investigators blinded to treatment allocation.
The primary outcome was postoperative pain intensity measured using the Visual Analog Scale (VAS) at predefined time points after extubation. Secondary outcomes included cumulative opioid consumption during the first 24 postoperative hours, postoperative nausea and vomiting (PONV), and block-related complications. Additional recovery-related outcomes included duration of mechanical ventilation, time to first mobilization, and intensive care unit (ICU) length of stay. These recovery outcomes were analyzed as exploratory endpoints because important perioperative factors influencing recovery were not systematically collected.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Tuşba
-
Van, Tuşba, Tyrkiet (Türkiye), 65080
- Van Yuzuncu Yil University Faculty of Medicine Department of anesthesiology and reanimation
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Adults aged 20 years and older ASA physical status II-IV Scheduled for elective coronary artery bypass grafting (CABG) via median sternotomy Extubated in the intensive care unit after surgery Provided written informed consent
Exclusion Criteria:
Refusal to participate or inability to provide informed consent Pregnancy Known allergy or contraindication to bupivacaine or other amide local anesthetics Coagulopathy or ongoing anticoagulation precluding regional anesthesia Local infection at the planned injection site Severe hepatic or renal failure Pre-existing chronic opioid use or chronic pain requiring opioid treatment Pre-existing neurological disorders affecting pain assessment Requirement for emergency surgery or concomitant cardiac procedures other than isolated CABG Reoperation for postoperative bleeding before outcome assessment
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Bilateral SAP Block
Participants undergoing elective coronary artery bypass grafting received an ultrasound-guided bilateral serratus anterior plane (SAP) block using 20 mL of 0.25% bupivacaine on each side. To maintain study blinding, ultrasound-guided placebo injections consisting of 20 mL of 0.9% saline were also administered bilaterally at the PECS II injection sites using identical coded syringes. |
Ultrasound-guided bilateral serratus anterior plane (SAP) block performed using 20 mL of 0.25% bupivacaine on each side after ICU admission while patients remained intubated following elective coronary artery bypass grafting. |
|
Aktiv komparator: Bilateral PECS II Block
Participants undergoing elective coronary artery bypass grafting received an ultrasound-guided bilateral PECS II block using 20 mL of 0.25% bupivacaine on each side. To maintain study blinding, ultrasound-guided placebo injections consisting of 20 mL of 0.9% saline were also administered bilaterally at the serratus anterior plane injection sites using identical coded syringes. |
Ultrasound-guided bilateral PECS II block was performed using the standard two-injection technique after ICU admission while patients remained intubated following elective coronary artery bypass grafting. On each side, a total of 20 mL of 0.25% bupivacaine was injected between the pectoralis major and minor muscles and between the pectoralis minor and serratus anterior muscles. |
|
Placebo komparator: Sham Block
Participants undergoing elective coronary artery bypass grafting received ultrasound-guided bilateral placebo injections consisting of 20 mL of 0.9% saline on each side at both the PECS II and serratus anterior plane injection sites using identical coded syringes to maintain study blinding. All participants received the same standardized postoperative systemic analgesic regimen. |
Ultrasound-guided bilateral sham fascial plane procedure was performed after ICU admission while patients remained intubated following elective coronary artery bypass grafting. On each side, 20 mL of 0.9% saline was injected at both the PECS II and serratus anterior plane injection sites using identical coded syringes to maintain study blinding. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative pain intensity assessed using the Visual Analog Scale (VAS)
Tidsramme: 4, 8, 12, and 24 hours after extubation
|
Postoperative pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. Assessments will be performed at 4, 8, 12, and 24 hours after extubation. |
4, 8, 12, and 24 hours after extubation
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative nausea and vomiting (PONV)
Tidsramme: Within 24 hours after surgery
|
The occurrence of postoperative nausea and/or vomiting will be recorded during the first 24 hours after surgery. |
Within 24 hours after surgery
|
|
Block-related complications
Tidsramme: During hospitalization
|
Block-related complications, including local anesthetic systemic toxicity, hematoma, infection, pneumothorax, vascular puncture, nerve injury, or other procedure-related adverse events, will be recorded. |
During hospitalization
|
|
Length of intensive care unit (ICU) stay
Tidsramme: From ICU admission to ICU discharge (assessed up to 30 days).
|
Length of stay in the intensive care unit (ICU), measured in hours from ICU admission to ICU discharge. |
From ICU admission to ICU discharge (assessed up to 30 days).
|
|
Time to first mobilization
Tidsramme: From ICU admission to first mobilization (assessed up to 7 days).
|
Time from ICU admission to first mobilization, measured in hours. |
From ICU admission to first mobilization (assessed up to 7 days).
|
|
Duration of mechanical ventilation
Tidsramme: From ICU admission to successful extubation (assessed up to 7 days).
|
Duration of mechanical ventilation, measured as the time from ICU admission to successful extubation, in hours. |
From ICU admission to successful extubation (assessed up to 7 days).
|
|
Total tramadol and pethidine consumption within the first 24 postoperative hours
Tidsramme: Within the first 24 postoperative hours
|
Cumulative intravenous tramadol and pethidine doses administered during the first 24 postoperative hours will be recorded and reported separately in milligrams. |
Within the first 24 postoperative hours
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: School of Mdicine Department of Anesthesiology and Reanimation, Yuzuncu Yil University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- YYU-2022-03
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
No individual participant data (IPD) will be shared with other researchers.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 .