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A COMPARISON OF NOVEL REGIONAL ANALGESIC MODALITIES IN PAEDIATRIC CARDIAC SURGERIES

EVALUATION OF THE TRANSVERSUS THORACIC MUSCLE AND THORACIC RETROLAMINAR PLANE BLOCK AS NOVEL ANALGESIC MODALITIES IN PEDIATRIC OPEN HEART SURGERIES

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/11/047110
Enrollment
138
Registered
2022-11-07
Start date
Unknown
Completion date
Unknown
Last updated
2022-11-21

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

Conditions

Health Condition 1: Q211- Atrial septal defect Health Condition 2: Q212- Atrioventricular septal defect Health Condition 3: Q21- Congenital malformations of cardiac septa Health Condition 4: Q232- Congenital mitral stenosis Health Condition 5: O- Medical and Surgical Health Condition 6: O- Medical and Surgical Health Condition 7: Q213- Tetralogy of Fallot Health Condition 8: Q210- Ventricular septal defect

Interventions

Intervention1: transversus thoraces muscle plane block OR Thoracic retrolaminar block: The present RCT aims to conduct a randomized comparison of post-operative 24 hours opioid requirement among thre

Sponsors

GANDHI MEDICAL COLLEGE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All Pediatric age group (2-12 yrs) with Congenital Heart Disease undergoing open heart surgery. ASA GRADE 1 and ASA GRADE 2

Exclusion criteria

Exclusion criteria: Exclusion criteria included repeated cardiac surgery, emergency surgery, prolonged intubation of patients, patients receiving high inotropic support, presence of pulmonary hypertension, bleeding disorders, and allergy to the amide local anesthetics.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure will be the total dose of opioid consumption in the first postoperative 24 h.Timepoint: First postoperative 24 h.—

Secondary

MeasureTime frame
The secondary outcome measures will be total intraoperative opiois consumption, postoperative Modified Objective pain score at rest, time to extubation, time to the first rescue analgesia dose, ICU length of stay, and the incidence of Thoracic retrolaminar block or Transversus thoraces plane block adverse events (hypotension, pneumothorax, vascular or neurological injury, local anesthetic toxicity). The incidence of other adverse events (vomiting and pruritus) will be also reported. Postoperative pain (MOPS) will be assessed during rest at 0, 2, 4, 8, 12, 16, 20, 24 h postoperatively.Timepoint: starting from beginning of anestheisa and ends 24 hours post-operatively.—

Countries

India

Contacts

Public ContactBRAJESH KAUSHAL

GANDHI MEDICAL COLLEGE, BHOPAL MP (INDIA)

brajeshkaushal3@gmail.com8839551736

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026