Study for assessing technique for pain relief in children undergoing cleft lip surgery.

A double blinded randomised controlled study on the effectiveness of post operative analgesia - comparison between ultrasound versus anatomical landmark technique of blocking bilateral maxillary nerve (suprazygomatic branch) in pediatric patients undergoing cleft lip and palate repair.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/03/050425

Enrollment

Registered

2023-03-07

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

Health Condition 1: Q375- Cleft hard and soft palate with unilateral cleft lip

Interventions

Intervention1: Ultrasound: Ultrasound guided Nerve Block Control Intervention1: Anatomical Landmark: Anatomical landmark based Nerve Block

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing Primary Cleft defect repair. Aged 6 months to 7 years Both sexes Elective Surgeries

Exclusion criteria

Exclusion criteria: ASA III (asthma with marked stridor, asd >5mm, unrepaired VSD, TOF, Eisenmenger syndrome, bleeding disorder) infection at the injection site, allergy to the local anesthetics, associated syndromes producing facial anomalies, Parents refusal.

Design outcomes

Primary

Measure	Time frame
Adequacy for pain relief assessed by FLACC score for postoperative pain.Timepoint: 2hr, 4hr, 6hr, 8hr, 10hr, 12hr, 14hr, 16hr, 18hr, 20hr, 22hr, 24hr	—

Secondary

Measure	Time frame
1. Time taken to administer the block 2. The total amount of rescue analgesic requirements during first the 24 h 3. Any complications related to block administration.Timepoint: 1. Total time in seconds from start of giving the block to end of finishing the block. 2. every 30minutes from end of surgery till first two hours and then every 2 hours till 24 hours 3. measured at the end of 24 hours after surgery.	—

Measure

Time frame

1. Time taken to administer the block 2. The total amount of rescue analgesic requirements during first the 24 h 3. Any complications related to block administration.Timepoint: 1. Total time in seconds from start of giving the block to end of finishing the block. 2. every 30minutes from end of surgery till first two hours and then every 2 hours till 24 hours 3. measured at the end of 24 hours after surgery.

—

Countries

India

Contacts

Public ContactDr Gayathri B

SRM Institute Of Science and Technology

gayathrii.r@gmail.com9500092905

Outcome results

None listed

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