Clinical trial NCT05518266: Sonar Guided vs Surgeon Delivered Parasternal Block
Official title: Ultrasound-guided Versus Surgeon Delivered Post-incisional Parasternal Block in Adult Patients Undergoing Open Cardiac Surgery: Are They the Same?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parasternal Intercostal Nerve Block
Keywords: pectointercostal fascial plane block
parasternal block
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

1. 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
2. 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.

Eligibility criteria: 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,

Primary outcomes:
measure: Change in postoperative pain score
timeFrame: 24 hours
Secondary outcomes:
measure: Amount of rescue analgesia
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
citation: Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.
citation: Huang AP, Sakata RK. [Pain after sternotomy - review]. Rev Bras Anestesiol. 2016 Jul-Aug;66(4):395-401. doi: 10.1016/j.bjan.2014.09.003. Epub 2015 Mar 18. Portuguese.
citation: Vilite B, Strike E, Rutka K, Leibuss R. Pain management in intensive care unit patients after cardiac surgery with sternotomy approach. Acta Med Litu. 2019;26(1):51-63. doi: 10.6001/actamedica.v26i1.3956.