- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07911943
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
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.
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 1
Kontakty i lokalizacje
Lokalizacje studiów
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Abbassia
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Cairo, Abbassia, Egipt, 00202
- Ain Shams University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Age: 40-70 years.
- Sex: Males and Females.
- American Society of Anaesthesiologists (ASA) Physical Status Class III.
- Scheduled for elective on-pump isolated CABG via median sternotomy for 1 or 2 coronary vessel grafts.
- Good left ventricular systolic function with ejection fraction (EF) >50%
Exclusion Criteria:
- Declining to give a written informed consent.
- History of allergy to the medications used in the study.
- 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).
- Psychiatric disorders or significant cognitive dysfunction.
- American Society of Anaesthesiologists (ASA) Physical Status Class IV or higher.
- Chronic use of opioids.
- Morbid obesity (BMI > 40 kg/m2).
- Patient with severe pulmonary disease.
- Patient who requires emergency CABG operation or redo cardiac surgery.
- Post operative intra-aortic balloon or extracorporeal membrane oxygenation (ECMO).
- Patient who will be operated for bleeding, tamponade or any reason for revision postoperatively.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny 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. |
|
Aktywny 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. |
|
Inny: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Duration of analgesia in hours
Ramy czasowe: up to 12 hours
|
up to 12 hours
|
|
|
Postoperative visual analogue pain score (VAS)
Ramy czasowe: 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
Ramy czasowe: up to 18 hours
|
Total doses of intra , postoperative fentanyl consumption and doses of rescue fentanyl. |
up to 18 hours
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Intra and postoperative haemodynamic data
Ramy czasowe: 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
Ramy czasowe: for 12 hours
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Postoperative extubation time in minutes. |
for 12 hours
|
|
Patients with block-related side effects and complications
Ramy czasowe: for 3 days
|
bleeding , hematoma , inflammation , nerve injury , hemodynamic changes |
for 3 days
|
|
Pulmonary function assessment
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- Grant MC, Chappell D, Gan TJ, Manning MW, Miller TE, Brodt JL; PeriOperative Quality Initiative (POQI) and the Enhanced Recovery After Surgery (ERAS) Cardiac Society Workgroup. Pain management and opioid stewardship in adult cardiac surgery: Joint consensus report of the PeriOperative Quality Initiative and the Enhanced Recovery After Surgery Cardiac Society. J Thorac Cardiovasc Surg. 2023 Dec;166(6):1695-1706.e2. doi: 10.1016/j.jtcvs.2023.01.020. Epub 2023 Jan 28.
- Young I, Dunning J, Mourad F, Escaloni J, Bliton P, Fernandez-de-Las-Penas C. Clinimetric analysis of the visual analogue scale and pain free mouth opening in patients with muscular temporomandibular disorder. Cranio. 2026 Jan;44(1):143-149. doi: 10.1080/08869634.2025.2464227. Epub 2025 Feb 10.
- Tao X, Xue FS, Hu B, Tian T. Letter to the Editor Regarding Serratus Anterior Plane Block Combined with General Analgesia and Patient-Controlled Serratus Anterior Plane Block in Patients with Breast Cancer: A Randomized Control Trial. Adv Ther. 2021 Aug;38(8):4592-4595. doi: 10.1007/s12325-021-01847-y. Epub 2021 Jul 18. No abstract available.
- Peterson W, Tse B, Martin R, Fralick M, Sholzberg M. Evaluating hemostatic thresholds for neuraxial anesthesia in adults with hemorrhagic disorders and tendencies: A scoping review. Res Pract Thromb Haemost. 2021 May 4;5(4):e12491. doi: 10.1002/rth2.12491. eCollection 2021 May.
- Leviel F, Fourdrain A, Delatre F, De Dominicis F, Lefebvre T, Bar S, Alshatri HY, Lorne E, Georges O, Berna P, Dupont H, Meynier J, Abou-Arab O. S erratus anterior plane block alone, paravertebral block alone and their combination in video-assisted thoracoscopic surgery: the THORACOSOPIC double-blind, randomized trial. Eur J Cardiothorac Surg. 2024 Mar 29;65(4):ezae082. doi: 10.1093/ejcts/ezae082.
- Kwa CXW, Cui J, Lim DYZ, Sim YE, Ke Y, Abdullah HR. Discordant American Society of Anesthesiologists Physical Status Classification between anesthesiologists and surgeons and its correlation with adverse patient outcomes. Sci Rep. 2022 May 2;12(1):7110. doi: 10.1038/s41598-022-10736-5.
- Givtaj N, Hosseinzadeh E, Hadipourzadeh FS, Faritous Z, Askari MH, Ghanbari Garekani M. Goal-directed therapy in cardiovascular surgery: A case series study. J Cardiovasc Thorac Res. 2023;15(3):186-192. doi: 10.34172/jcvtr.2023.31838. Epub 2023 Sep 23.
- Delijani D, Kim H, Huang X, Pena J, Hartman A, Yu PJ. Predictors of Postoperative Morphine Milligram Equivalents in Cardiac Surgery. J Cardiothorac Vasc Anesth. 2024 Dec;38(12):3094-3100. doi: 10.1053/j.jvca.2024.08.029. Epub 2024 Aug 23.
- • Azzouzi Idrissi, O., Aouni, H., Shimi, A., Bechri, I., Derkaoui, A. & Khatouf, M.,(2024). Preoperative evaluation in cardiac surgery: A prospective study in an intensive care unit in Morocco. World Journal of Advanced Research and Reviews, 21(3), pp.2207-2213.
- Alkhouli M, Alqahtani F, Kalra A, Gafoor S, Alhajji M, Alreshidan M, Holmes DR, Lerman A. Trends in Characteristics and Outcomes of Patients Undergoing Coronary Revascularization in the United States, 2003-2016. JAMA Netw Open. 2020 Feb 5;3(2):e1921326. doi: 10.1001/jamanetworkopen.2019.21326.
- Albi-Feldzer A, Dureau S, Ghimouz A, Raft J, Soubirou JL, Gayraud G, Jayr C. Preoperative Paravertebral Block and Chronic Pain after Breast Cancer Surgery: A Double-blind Randomized Trial. Anesthesiology. 2021 Dec 1;135(6):1091-1103. doi: 10.1097/ALN.0000000000003989.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- FMASU MD381/2025
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
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Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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