A clinical trial to compare whether children after undergoing surgery in hard palate, (roof of mouth) eat sooner with reducing the sensation by blocking the nerve or with injecting local anaesthetic drug directly into the palate.

Comparison of ultrasound guided suprazygomatic maxillary nerve block with palatine infiltration of local anaesthetic promoting early adequate oral intake among children undergoing palatoplasty - A Randomized Controlled Trial. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/058108

Enrollment

Registered

2023-09-27

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Ultrasound Guided Suprazygomatic Maxillary Nerve Block: Ultrasound Guided Suprazygomatic Maxillary Nerve Block by Suprazygomatic approach will be performed on either side with 0.2ml/kg

Eligibility

Inclusion criteria

Inclusion criteria: All children upto 12 years of age, of both sexes, with ASA class I and II scheduled for surgical repair of cleft palate under general anaesthesia

Exclusion criteria

Exclusion criteria: 1) Patients with history of developmental delay or mental retardation 2) Patients with hypersensitivity to local anaesthetics 3) Patients with bleeding diathesis 4) Patients with skin lesions or wounds at puncture site of block 5) Patients with congenital facial anomalies (which includes syndromic patients with features like micrognathia and retrognathia)

Design outcomes

Primary

Measure	Time frame
To compare the time taken for first adequate(minimum of 5ml/kg or 50ml whichever is achievable) oral intake with maxillary nerve block and palatine infiltration of local anaesthetic among children undergoing palatoplastyTimepoint: Postoperative period	—

Secondary

Measure	Time frame
To compare incidence of postoperative nausea vomiting and respiratory adverse eventsTimepoint: Postoperative period(24 to 48Hrs);To compare parents satisfactionTimepoint: At the time of discharge;To compare the cumulative intra and postoperative opioid consumptionTimepoint: Postoperative period(24 to 48Hrs);To compare the postoperative pain scores between two groupsTimepoint: Pain will be measured soon after shifting to ICU then at 1,4,8,12,18 and 24 hours postoperatively	—

Measure

Time frame

To compare incidence of postoperative nausea vomiting and respiratory adverse eventsTimepoint: Postoperative period(24 to 48Hrs);To compare parents satisfactionTimepoint: At the time of discharge;To compare the cumulative intra and postoperative opioid consumptionTimepoint: Postoperative period(24 to 48Hrs);To compare the postoperative pain scores between two groupsTimepoint: Pain will be measured soon after shifting to ICU then at 1,4,8,12,18 and 24 hours postoperatively

—

Countries

India

Contacts

Public ContactDr Kerthi Hassthan T

Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)

sakthiab8@gmail.com8903468132

Outcome results

None listed

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