Ultrasound-guided Versus Surgeon Delivered Post-incisional Parasternal Block in Adult Patients Undergoing Open Cardiac Surgery: Are They the Same?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 88
- Primary Endpoint
- Change in postoperative pain score
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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,
Arms & Interventions
US-guided post-incisional PIFB
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
Intervention: US-guided Parasternal block (Procedure)
Surgeon-delivered post-incisional 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.
Intervention: Surgeon-delivered parasternal block (Procedure)
Outcomes
Primary Outcomes
Change in postoperative pain score
Time Frame: 24 hours
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"
Secondary Outcomes
- Amount of rescue analgesia(24 hours)
Investigators
Mohamed Ahmed Ali Ahmed
Doctor
Assiut University