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Efficacy of incisional local anesthetic infiltration by multi-orifice catheter for pain relief in pediatric patient undergoing cardiac surgery

Efficacy of incisional ropivacaine infiltration by pre-sternal multi-orifice catheter for post-sternotomy pain relief in pediatric patient undergoing cardiac surgery – A prospective, randomized, control study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/044385
Enrollment
160
Registered
2022-07-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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: Q208- Other congenital malformations ofcardiac chambers and connections Health Condition 3: I998- Other disorder of circulatory system Health Condition 4: I52- Other heart disorders in diseasesclassified elsewhere Health Condition 5: Q213- Tetralogy of Fallot Health Condition 6: Q210- Ventricular septal defect

Interventions

Intervention1: infiltration group: incisional ropivacaine infiltration bolus 8hourly for 48hrby pre-sternal multi-orifice catheter Control Intervention1: infusion group: incisional ropivacaine infusio

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All elective cardiac surgeries in paediatric patients with acyanotic heart disease of age groups 6 months to 14 years 2. either sex 3. ASA 1 and 2 4.candidates for fast tracking and extubation within 6 hours postoperatively shall be included.

Exclusion criteria

Exclusion criteria: ?Emergency surgeries ?Redo surgeries ?Preoperative inotropic support ?Abnormal coagulation profile ?Preoperative ejection fraction ?Low-cardiac-output syndrome ?Recurrent ventricular arrhythmias ?Allergic to the amide type of local anaesthetics (LA)

Design outcomes

Primary

MeasureTime frame
post-sternotomy pain relief based on Modified Objective Pain Score (MOPS)Timepoint: The out come will be assessed in 2hr, 4hr, 8hr, 16hr, 24hr, 36hr and 48 hr—

Secondary

MeasureTime frame
1.Duration of analgesia and time to first dose of rescue analgesia 2.Amount of opioid usage 3.Duration of ICU and hospital stay 4.Fast tracking and early extubation ComplicationsTimepoint: for 48 hours—

Countries

India

Contacts

Public ContactDevishree Das

AIIMS, New Delhi

sdeep61@yahoo.com9873729366

Outcome results

None listed

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