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

Phase 3

Not yet recruiting

• Conditions: Health Condition 1: Q359- Cleft palate, unspecified

• Registration Number: CTRI/2022/01/039730
• Lead Sponsor: Himalayan Institute of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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