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Comparison of Analgesic Efficacy Between Ultrasound Guided Serratus Anterior Plane Block or Thoracic Paravertebral Block Versus Intravenous Fentanyl for On-pump Coronary Artery Bypass Graft Surgery

2. november 2026 oppdatert av: Ain Shams University

Comparison of Analgesic Efficacy Between Ultrasound Guided Serratus Anterior Plane Block or Thoracic Paravertebral Block Versus Intravenous Fentanyl for On-pump Coronary Artery Bypass Graft Surgery: A Prospective, Randomised, Controlled Clinical Study

Aim is to compare intra and postoperative analgesic efficacy of US-guided serratus anterior plane block (SAPB) or thoracic paravertebral block (TPVB) versus intravenous fentanyl in patient undergoing on-pump CABG surgery.

Studieoversikt

Detaljert beskrivelse

Aim is to compare intra and postoperative analgesic efficacy of US-guided serratus anterior plane block (SAPB) or thoracic paravertebral block (TPVB) versus intravenous fentanyl in patient undergoing on-pump CABG surgery.

The enrolled (111) patients will be randomly assigned via a computer-generated randomization table into three parallel and equivalent (1:1:1 ratio) groups: group A (37); will receive serratus anterior plane block, group B (37);will receive thoracic paravertebral block and group C (37); standard of care control group, will receive fentanyl infusion.

Group (A):

SAPB block will be performed Bilaterally. 20 ml of 0.25% bupivacaine hydrochloride [Maracine prepared by adding an equal volume (1:1) of normal saline (0.9%) to 0.5% bupivacaine]will be injected.

Group (B):

TPVB will be performed bilaterally. 20 ml of 0.25% bupivacaine [Maracine prepared by adding an equal volume (1:1) of normal saline (0.9%) to 0.5% bupivacaine] will be injected.

Group (C) (Control):

Patient will receive IV fentanyl infusion just before skin incision, which will be stopped when cardiopulmonary bypass (CPB) is on, then resumed after weaning form CPB and continued till the end of the surgery.500µg fentanyl will be mixed with 50 ml 0.9% normal saline in 50 ml syringe (10 µg /ml).Infusion rate will be determined according to a dose of 1µg /kg/h.

Studietype

Intervensjonell

Registrering (Antatt)

111

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Abbassia
      • Cairo, Abbassia, Egypt, 00202
        • Ain Shams University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Age: 40-70 years.
  2. Sex: Males and Females.
  3. American Society of Anaesthesiologists (ASA) Physical Status Class III.
  4. Scheduled for elective on-pump isolated CABG via median sternotomy for 1 or 2 coronary vessel grafts.
  5. Good left ventricular systolic function with ejection fraction (EF) >50%

Exclusion Criteria:

  1. Declining to give a written informed consent.
  2. History of allergy to the medications used in the study.
  3. Contraindications to regional anaesthesia as patient refusal, coagulopathy [activated partial thromboplastin time ≥45 sec, prothrombin time (INR) 1.5, platelets ≤ 80,000/dl], clopidogrel within the last 7 days of the procedure, severe spinal deformity or infection at puncture site).
  4. Psychiatric disorders or significant cognitive dysfunction.
  5. American Society of Anaesthesiologists (ASA) Physical Status Class IV or higher.
  6. Chronic use of opioids.
  7. Morbid obesity (BMI > 40 kg/m2).
  8. Patient with severe pulmonary disease.
  9. Patient who requires emergency CABG operation or redo cardiac surgery.
  10. Post operative intra-aortic balloon or extracorporeal membrane oxygenation (ECMO).
  11. Patient who will be operated for bleeding, tamponade or any reason for revision postoperatively.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: serratus anterior plane block

this group will be given 20 ml of 0.25% bupivacaine hydrochloride bilaterally

In SAPB; the needle is advanced in-plane from caudally cephalad at the midaxillary line at the level of the fourth rib with 45-degree angle, targeting the plane between the latissimus dorsi and serratus muscles. SAPB block will be performed Bilaterally. After confirmation that the needle tip is in the correct plane by injecting 2 ml of saline, 20 ml of 0.25% bupivacaine hydrochloride [Maracine prepared by adding an equal volume (1:1) of normal saline (0.9%) to 0.5% bupivacaine]will be injected, with intermittent aspiration to confirm neither air nor blood in the needle.

Aktiv komparator: thoracic paravertebral block

this group will be given 20 ml of 0.25% bupivacaine hydrochloride bilaterally

In TPVB; the needle is advanced in parasagittal plane over the transverse processes of the T4 and T5 vertebrae, about 2.5 cm lateral to the spinous processes, just deep to the superior costotransverse ligament but superficial to the parietal pleura. TPVB will be performed bilaterally. After confirmation that the needle tip is in the correct plane by injecting 2 ml of saline, 20 ml of 0.25% bupivacaine [Maracine prepared by adding an equal volume (1:1) of normal saline (0.9%) to 0.5% bupivacaine] will be injected, with intermittent aspiration to confirm no air or blood in the needle.

Annen: control

Intravenous fentanyl infusion 1µg /kg/h

Patient will receive IV fentanyl infusion just before skin incision, which will be stopped when cardiopulmonary bypass (CPB) is on, then resumed after weaning form CPB and continued till the end of the surgery.500µg fentanyl will be mixed with 50 ml 0.9% normal saline in 50 ml syringe (10 µg /ml).Infusion rate will be determined according to a dose of 1µg /kg/h.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Duration of analgesia in hours
Tidsramme: up to 12 hours
up to 12 hours
Postoperative visual analogue pain score (VAS)
Tidsramme: up to 12 hours

Postoperative visual analogue pain score (VAS): It will be recorded every 1 hour after admission to ICU for the first 4 hours ' then every 2 hours for the remaining 8 hours

up to 12 hours
Total dose of fentanyl
Tidsramme: up to 18 hours

Total doses of intra , postoperative fentanyl consumption and doses of rescue fentanyl.

up to 18 hours

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Intra and postoperative haemodynamic data
Tidsramme: up to 18 hours

Mean blood pressure (mmHg): Baseline, immediately after performing the block, at 30 minutes intervals (except when the patient on CPB) till the end of surgery Mean blood pressure (mmHg): Immediately after ICU admission, at 1 hour intervals in the 1st 6 hours, then at 2 hours intervals till 12 hours

up to 18 hours
Postoperative extubation time
Tidsramme: for 12 hours

Postoperative extubation time in minutes.

for 12 hours
Patients with block-related side effects and complications
Tidsramme: for 3 days

bleeding , hematoma , inflammation , nerve injury , hemodynamic changes

for 3 days
Pulmonary function assessment
Tidsramme: for 12 hours

Pulmonary function assessment [forced expiratory volume at one second as % of predicted) using spirometry: Every 6 hours after extubation up to 12 hours

for 12 hours
Intra and postoperative haemodynamic data. Heart rate
Tidsramme: up to 18 hours

Heart rate (beats/minute): Baseline, immediately after performing the block, at 30 minutes intervals (except when the patient on CPB) till the end of surgery Heart rate (beats/minute): Immediately after ICU admission, at 1 hour intervals in the 1st 6 hours, then at 2 hours intervals till 12 hours

up to 18 hours

Samarbeidspartnere og etterforskere

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Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2026

Primær fullføring (Antatt)

30. november 2026

Studiet fullført (Antatt)

30. desember 2026

Datoer for studieregistrering

Først innsendt

14. oktober 2026

Først innsendt som oppfylte QC-kriteriene

2. november 2026

Først lagt ut (Faktiske)

3. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

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UBESLUTTE

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Studerer et amerikansk FDA-regulert medikamentprodukt

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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