Ain shams university
Cairo, 20, Egypt
NCT Number: NCT05774249
Moderate to severe postoperative pain is usually encountered after cardiac surgery.Improper postoperative pain control could have multiple hemodynamic hazards in addition to prolonged postoperative ventilatory support and intensive care unit stay .The safety and efficacy of ultrasound guided chest wall plane blocks has been described for postoperative analgesia after cardiac surgeries.
Study objective: to investigate the effect of adding of pecto-intercostal fascial plane block on the postoperative pain control, perioperative analgesic consumptions and the time for ventilation weaning and intensive care unit discharge in patients who will undergo off-pump Coronary artery bypass surgeries.
Methods: This study patients will be randomly assigned to 2 Groups to receive preoperative ultrasound-guided pecto-intercostal fascial plane block with either 20 mL of 0.25% bupivacaine with adrenaline 1:400,000 or saline bilaterally.
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Notify Me30 year–70 year
All sexes
Interventional
Not applicable
Cairo, 20, Egypt
After preoperative patients' anesthesia assessment; the study patients (20 in each group) will receive general anesthesia under invasive monitoring of hemodynamics, and oxygen saturation. After anesthesia induction; cannulation of jugular vein and insertion of transoesophageal echocardiography and temperature probe will be done. In block group : while Patients in supine decubitus position,parasternal area will be scanned using high frequency ultrasound linear probe .After identification of ribs with intercostal spaces in between ;the fourth intercostal space will be approached via 10 cm block needle targeting the plane between pectoralis major and external intercostal muscle under ultrasound guidance after which 20 mL of 0.25% bupivacaine with adrenaline 1:400,000 will be administered in increments bilaterally. In control group:Sham Block will be done using 20 mL of normal saline 0.9% bilaterally .
Anesthesia will be maintained with sevoflurane inhalational anesthesia and incremental cisatracurium and fentanyl for intraoperative muscle relaxation and analgesia respectively. Intraoperative anticoagulation will be carried out before revascularization using intravenous heparin titrated according to activated clotting time ,which will be reversed after end of surgery using protamine sulfate.
At the end of surgery patients will be sent to post cardiac surgery intensive care unit . Postoperative analgesia in the form of intravenous paracetamol one gram will be administered on intensive care unit admission then fentanyl based patient controlled analgesia will be started . IV tramadol 1mg/kg as second rescue analgesia will be given if visual analogue scores are still ≥ 4.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
while Patients in supine decubitus position,parasternal area will be scanned using high frequency ultrasound linear probe .After identification of ribs with intercostal spaces in between ;the fourth intercostal space will be approached via 10 cm block needle targeting the plane between pectoralis major and external intercostal muscle under ultrasound guidance after which 20 mL of 0.25% bupivacaine with adrenaline 1:400,000 will be administered in increments bilaterally.
Sham Block will be done while Patients in supine decubitus position,parasternal area will be scanned using high frequency ultrasound linear probe .After identification of ribs with intercostal spaces in between ;the fourth intercostal space will be approached via 10 cm block needle targeting the plane between pectoralis major and external intercostal muscle under ultrasound guidance after which 20 mL of normal saline 0.9 % will be administered bilaterally.
Time frame: immediately after extubation
0 (no pain) and 10 (worst possible pain)
Time frame: 1 st hour after extubation
0 (no pain) and 100 (worst possible pain)
Time frame: 2 nd hour after extubation
0 (no pain) and 100 (worst possible pain)
Time frame: 4 th hour after extubation
0 (no pain) and 100 (worst possible pain)
Time frame: 8 th hour after extubation
0 (no pain) and 100 (worst possible pain)
Time frame: 12 th hour after extubation
0 (no pain) and 100 (worst possible pain)
Time frame: 18 th hour after extubation
0 (no pain) and 100 (worst possible pain)
Time frame: 24 th hour after extubation
0 (no pain) and 100 (worst possible pain)
Time frame: during the operation
Time frame: 24 hour after operation
Time frame: 24 hours after extubation
Time frame: at the end of surgery
Time frame: 72 hours after surgery
Time frame: 72 hours after surgery
Ain Shams University
Other
The Value of Adding Pecto-intercostal Fascial Plane Block on the Postoperative Analgesia and Recovery Profile After Off-Pump Coronary Artery Bypass Surgery
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