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The effect of maxillary nerve block for cleft palate surgery in children.

To study the effect of bilateral suprazygomatic maxillary nerve block for cleft palate repair in children.

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/01/039730
Enrollment
60
Registered
2022-01-25
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Health Condition 1: Q359- Cleft palate, unspecified

Interventions

Intervention1: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

Himalayan Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.ASA physical status I & II of either sex 2.Age between 9 months and 3 years 3.Scheduled for cleft palate repair under general anesthesia

Exclusion criteria

Exclusion criteria: 1.Lack of parental consent 2.ASA physical status III & IV 3.Patients with a history of allergy to local anesthetics or cutaneous infection around the sites of the block 4.History of developmental delay or mental retardation 5.Blleding diathesis and/or coagulation disorders 6.History of sleep apnea 7.Children with comorbid conditions like congenital heart disease, airway obstructive diseases and central nervous system disorders 8.Peripheral neuropathy or chronic pain syndrome 9.Associated cleft lip 10.Concomitant rhinoplasty 11.Current treatment for pain relief 12.The need for post operative ventilation

Design outcomes

Primary

MeasureTime frame
To determine the efficacy of bilateral suprazygomatic maxillary nerve block in terms of decreased post operative pain, decrease in post operative emergence delirium and decrease in post operative sedationTimepoint: To assess post operative pain at 0,1,2,4,6,8,12,18 and 24 hours;To assess post operative emergence delirium at 0,5,10,15,25 and 30 minutes;To assess post operative sedation at 0,1,2,4,6,8,12,18 and 24 hours.

Secondary

MeasureTime frame
To monitor intraoperative hemodynamic parameters, adverse events related to the block in the immediate postoperative periodTimepoint: At the time of induction, intubation/start of study agent, time of surgery then every 5 min after the start of study thereafter every 10 min till the patient is extubated

Countries

India

Contacts

Public ContactDr Sonal Singhal

Himalayan Institute of Medical Sciences

sonaldoonsinghal@gmail.com8755314477

Outcome results

None listed

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