Pecto-intercostal Fascial Plane Block for Postoperative Analgesia and Recovery Profile After Off-Pump Coronary Artery Bypass Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Value of Adding Pecto-intercostal Fascial Plane Block on the Postoperative Analgesia and Recovery Profile After Off-Pump Coronary Artery Bypass Surgery

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: Ultrasound guided pecto-intercostal Fascial Plane Block using bupivacaine
* Procedure: Ultrasound guided pecto-intercostal Fascial Plane Block using normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound guided pectointercostal fascial plane block group<br>using 20 mL of 0.25% bupivacaine with adrenaline 1:400,000 | Procedure: Ultrasound guided pecto-intercostal Fascial Plane Block using bupivacaine<br>* 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.<br>|
| Placebo Comparator: control group<br>using 20 mL of normal saline 0.9% | Procedure: Ultrasound guided pecto-intercostal Fascial Plane Block using normal saline<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue score | 0 (no pain) and 10 (worst possible pain) | immediately after extubation | 
| visual analogue score | 0 (no pain) and 100 (worst possible pain) | 1 st hour after extubation | 
| visual analogue score | 0 (no pain) and 100 (worst possible pain) | 2 nd hour after extubation | 
| visual analogue score | 0 (no pain) and 100 (worst possible pain) | 4 th hour after extubation | 
| visual analogue score | 0 (no pain) and 100 (worst possible pain) | 8 th hour after extubation | 
| visual analogue score | 0 (no pain) and 100 (worst possible pain) | 12 th hour after extubation | 
| visual analogue score | 0 (no pain) and 100 (worst possible pain) | 18 th hour after extubation | 
| visual analogue score | 0 (no pain) and 100 (worst possible pain) | 24 th hour after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total intraoperative opioid consumption |  | during the operation | 
| Total postoperative opioid consumption |  | 24 hour after operation | 
| Number of patients need postoperative rescue tramadol |  | 24 hours after extubation | 
| Time to patient extubation |  | at the end of surgery | 
| time for ICU discharge |  | 72 hours after surgery | 
| postoperative complication |  | 72 hours after surgery |