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Parasternal Block in Pediatric Patients Undergoing Cardiac Surgery

Optimal Timing of Parasternal Intercostal Nerve Block in Pediatric Patients Undergoing Cardiac Surgery

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05539885
Enrollment
80
Registered
2022-09-14
Start date
2022-10-31
Completion date
2023-11-30
Last updated
2022-09-19

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

Conditions

Pectointercostal Fascial Plane Block

Keywords

pectointercostal fascial plane block, pediatrics, open cardiac surgery, optimal timing

Brief summary

The objective of this study is to determine whether the use of post-incisional surgeon-delivered parasternal block in children undergoing congenital heart surgery is associated with differences in outcomes when compared to ultrasound-guided pre-incisional parasternal block in the form of Pectointercostal fascial plane block (PIFB).

Detailed description

Although many studies have found that pre-incisional parasternal block is effective in preventing postoperative sternotomy pain, we found no randomized controlled trials comparing pre-incisional vs post-incisional parasternal block in pediatric patients except for one retrospective cohort study done by Lisa et al comparing surgeon-delivered local anesthetic wound infiltration vs postoperative bilateral Petco-Intercostal Fascial Blocks. The post-incisional parasternal block may give prolonged postoperative pain control (equivalent to analgesia duration of pre-incisional parasternal block plus the duration of the operative procedure.)

Interventions

PROCEDUREPre-incisional Ultrasound guided (PIFP) block

Patients in group P will be injected with 0.4 mL/kg of 0.25 bupivacaine in the fascial plane between the internal intercostal and pectoralis major muscles on each side of the sternum after induction of anesthesia and before skin incision under ultrasound guidance.

PROCEDUREPost-incisional Surgeon delivered parasternal block group

After sternal closure, the surgeon will inject bupivacaine (0.5- to 2-mL aliquots depending on the weight) in the fascial plane under direct vision between the 5 anterior (2nd-6th) intercostal spaces on each side 1 to 1.5 cm lateral to the sternal edge using 25-gauge, 50 mm needle. The surgeon will inject the same dose and concentration of bupivacaine used in the ultrasound technique. This technique was prescribed before by Chaudhary et al (23). In both techniques, the maximum dose of bupivacaine will never be exceeded (2 mg/kg). In addition, all patients were administered 2 mL of 0.25% bupivacaine at the site of the mediastinal drain location.

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
2 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

Acyanotic Congenital heart disease; ASD (atrial septal defect), VSD (ventricular septal defect), and CAVC (common atrioventricular canal). Elective open-heart surgery 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. Children with cyanotic congenital heart disease. 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.

Design outcomes

Primary

MeasureTime frameDescription
Time to first analgesia request.24 hoursThe first analgesic request after extubation
Amount of rescue analgesia.24 hoursAmount of rescue analgesia (total dose of fentanyl) after extubation.

Secondary

MeasureTime frameDescription
Postoperative pain score:at extubation, 2nd, 6th, 12th, 16th, 20th, and 24th hour after extubation.Postoperative pain will be assessed by modified objective pain score (MOPS) in children at 0, 2, 6, 12, 16, 20, and 24 h after extubation. Wilson and Doyle modified the objective pain score by replacing blood pressure with posture. MOPS consists of 5 items (crying, movements, agitations, posture, and verbal). The minimum score is 0 (No pain) and the maximum is 10 (most sever pain).
Intraoperative fentanyl consumptiontime of surgery

Contacts

Primary ContactMohamed Ahmed Ali Ahmed, MD
drmoali@yahoo.com+201008707460
Backup ContactAlaa Attia, MD

Outcome results

None listed

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