Clinical trial NCT05774249: Pecto-intercostal Fascial Plane Block for Postoperative Analgesia and Recovery Profile After Off-Pump Coronary Artery Bypass Surgery
Official title: The Value of Adding Pecto-intercostal Fascial Plane Block on the Postoperative Analgesia and Recovery Profile After Off-Pump Coronary Artery Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* NYHA ( New york heart association ) class I- III

Exclusion Criteria:

* Parents' refusal to study participation.
* Patients with poor coronary vessels targets.
* Patients with poor cardiac systolic function or preoperative hemodynamic unstability
* Redo coronary artery bypass surgery
* Intraoperative complication need conversion to on pump surgery
* Postoperative exploration for bleeding or poor coronary revascularization
* Advanced COPD(chronic obstructive pulmonary disease) patients.
* Myopathies and myasthenic patients
* Allergy to study medications

Primary outcomes:
measure: visual analogue score
timeFrame: immediately after extubation
measure: visual analogue score
timeFrame: 1 st hour after extubation
measure: visual analogue score
timeFrame: 2 nd hour after extubation
measure: visual analogue score
timeFrame: 4 th hour after extubation
measure: visual analogue score
timeFrame: 8 th hour after extubation
measure: visual analogue score
timeFrame: 12 th hour after extubation
measure: visual analogue score
timeFrame: 18 th hour after extubation
measure: visual analogue score
timeFrame: 24 th hour after extubation
Secondary outcomes:
measure: Total intraoperative opioid consumption
timeFrame: during the operation
measure: Total postoperative opioid consumption
timeFrame: 24 hour after operation
measure: Number of patients need postoperative rescue tramadol
timeFrame: 24 hours after extubation
measure: Time to patient extubation
timeFrame: at the end of surgery
measure: time for ICU discharge
timeFrame: 72 hours after surgery
measure: postoperative complication
timeFrame: 72 hours after surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university
Study officials:
References: