Sonar Guided vs Surgeon Delivered Parasternal Block

NCT ID: NCT05518266

Last Updated: 2022-09-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-31
• Study Completion Date: 2023-12-31

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.

Conditions

Parasternal Intercostal Nerve Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

US-guided Parasternal block

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

Surgeon-delivered parasternal block

Intervention Type: PROCEDURE

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.

Interventions

US-guided Parasternal 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

Intervention Type: PROCEDURE

Surgeon-delivered parasternal block

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.

Intervention Type: PROCEDURE

Other Intervention Names

Pectointercostal fascial plane block

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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Ahmed Ali Ahmed

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mohamed Ahmed Ali Ahmed

Role: CONTACT

drmoali@yahoo.com

+201008707460

References

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.

Reference Type: RESULT

PMID: 31054241 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25796483 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31281217 (View on PubMed)

Other Identifiers

PIFPB Adults

Identifier Type: -

Identifier Source: org_study_id