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Sonar Guided vs Surgeon Delivered Parasternal Block

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05518266
Enrollment
88
Registered
2022-08-26
Start date
2022-10-31
Completion date
2023-12-31
Last updated
2022-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parasternal Intercostal Nerve Block

Keywords

pectointercostal fascial plane block, parasternal block

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.

Interventions

PROCEDUREUS-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

PROCEDURESurgeon-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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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,

Design outcomes

Primary

MeasureTime frameDescription
Change in postoperative pain score24 hoursPostoperative 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

MeasureTime frameDescription
Amount of rescue analgesia24 hoursAmount of rescue analgesia (total dose of fentanyl) during the first 24 hours after extubation.

Contacts

Primary ContactMohamed Ahmed Ali Ahmed
drmoali@yahoo.com+201008707460

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026