Sonar Guided vs Surgeon Delivered Parasternal Block

Study Overview
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Brief Summary
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The objective of this study is to determine whether the use of post-incisional surgeon-delivered parasternal block is at least non-inferior in relieving postoperative pain in adult patients scheduled for cardiac surgery involving sternotomy compared with ultrasound-guided post-incisional PIFB.

Detailed Description
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Patients will be randomly allocated (using a sequence of computer-generated random numbers) into one of two groups (44 patients in each); group P (ultrasound guided parasternal; PIFP block) and group S (surgeon delivered parasternal block). group P (ultrasound guided parasternal; PIFP block): Bupivacaine 0.25 % will be injected into the fascial plane between the pectoralis major muscle and external intercostal muscle or costal cartilages on each side of sternum after skin closure under ultrasound guidance Group S (surgeon delivered parasternal block). Just before wiring the sternum, the surgeon will inject bupivacaine 0.25 % in 4 mL aliquots into the anterior (2nd-6th) intercostal spaces on each side about 2 cm lateral to the sternal edge with a total volume of 40 mL under direct vision.

Official Title
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Ultrasound-guided Versus Surgeon Delivered Post-incisional Parasternal Block in Adult Patients Undergoing Open Cardiac Surgery: Are They the Same?

Conditions
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Parasternal Intercostal Nerve Block

Intervention / Treatment
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* Procedure: US-guided Parasternal block
* Procedure: Surgeon-delivered parasternal block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: from 18 to 75 years. Rheumatic heart disease needing elective valve replacement (mitral, aortic, or double valve replacement) via median sternotomy and under CPB (cardiopulmonary bypass) Hemodynamic stability (no evidence of heart failure, not on vasoactive drugs, and not on mechanical ventilation). Exclusion Criteria: • Previous, urgent, or emergent cardiac surgery. Patients undergoing coronary artery bypass grafting (CABG) local infection of the skin at the site of needle puncture, Allergy to bupivacaine, Coagulation disorders, Clinically significant liver or kidney disease, Heart failure or severe pulmonary hypertension. severe renal, pulmonary, liver, or endocrine systemic disease,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: US-guided post-incisional PIFB<br>Bupivacaine 0.25 % will be injected into the fascial plane between the pectoralis major muscle and external intercostal muscle or costal cartilages on each side of the sternum after skin closure under ultrasound guidance | Procedure: US-guided Parasternal block<br>* Bupivacaine 0.25 % will be injected into the fascial plane between the pectoralis major muscle and external intercostal muscle or costal cartilages on each side of sternum after skin closure under ultrasound guidance<br>* Other names: Pectointercostal fascial plane block;|
| Active Comparator: Surgeon-delivered post-incisional parasternal block<br>Just before wiring the sternum, the surgeon will inject bupivacaine 0.25 % in 4 mL aliquots into the anterior (2nd-6th) intercostal spaces on each side about 2 cm lateral to the sternal edge with a total volume of 40 mL under direct vision. | Procedure: Surgeon-delivered parasternal block<br>* Just before wiring of the sternum, the surgeon will inject bupivacaine 0.25 % in 4 mL aliquots into the anterior (2nd-6th) intercostal spaces on each side about 2 cm lateral to the sternal edge with a total volume of 40 mL under direct vision.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in postoperative pain score | Postoperative pain score will be measured after extubation at 0, 3, 6, 12, 16, 20, and 24 hours, using a visual analog scale (VAS). We are interested in the time at which postoperative pain is most severe. The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually, 10centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. A score of 0 is no pain and a score of 10 is worst imaginable pain | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of rescue analgesia | Amount of rescue analgesia (total dose of fentanyl) during the first 24 hours after extubation. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pectointercostal fascial plane block, parasternal block