A study to compare the pain relief by two modalities pudendal and caudal block in children undergoing genital surgeries.

Comparative study on perioperative analgesic efficacy of Ultrasound guided Pudendal neve block and caudal block in Pediatric patients undergoing penile procedures: a prospective randomised controlled non inferiority study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/060126

Enrollment

Registered

2023-11-22

Start date

Unknown

Completion date

Unknown

Last updated

2023-12-19

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 PUDENDAL NERVE BLOCK: This block involves the identification of the ischial spine, the patient is placed supine in a frog leg position the ultrasound linear high-frequ

the sacrococcygeal ligament superiorly and the dorsal bony surface of the sacrum inferiorly can be seen, with the sacral hiatus seen as a hypoechoic area in between. A 22-gauge needle is then inserted

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age 2-7 years 2.ASA 1 and 2 patients 3.Undergoing penile surgeries( urethroplasty, chordee correction, and correction of urethrocutaneous fistula) under general anesthesia

Exclusion criteria

Exclusion criteria: 1.Presence of a congenital heart disease 2.Presence of respiratory, renal, or hepatic dysfunction 3.ASA III and IV 4.Local infection 5.Coagulopathy

Design outcomes

Primary

Measure	Time frame
Compare Between-group differences in the FLACC pain scoresTimepoint: 6 hour	—

Secondary

Measure	Time frame
Complications of the block – hematoma, infection, Bradycardia, Hypotension, nausea, vomiting, block failure, duration of motor blockade.Timepoint: Up to 24 hours post-surgery;Duration of post-anesthesia care unit stayTimepoint: Up to 24 hours post-surgery;Intraoperative and postoperative opioid consumptionTimepoint: 0, 30min, 60min, 120min, 6, 10, 12,18,24 hrs;Postoperative Pain Assessment (FLACC Scale)Timepoint: 0, 30min, 60min, 120min, 6, 10, 12,18,24 hrs;Time to first rescue analgesiaTimepoint: Up to 24 hours post-surgery;Total analgesic consumption (acetaminophen/ketorolac)Timepoint: at 24 hours	—

Measure

Time frame

Complications of the block – hematoma, infection, Bradycardia, Hypotension, nausea, vomiting, block failure, duration of motor blockade.Timepoint: Up to 24 hours post-surgery;Duration of post-anesthesia care unit stayTimepoint: Up to 24 hours post-surgery;Intraoperative and postoperative opioid consumptionTimepoint: 0, 30min, 60min, 120min, 6, 10, 12,18,24 hrs;Postoperative Pain Assessment (FLACC Scale)Timepoint: 0, 30min, 60min, 120min, 6, 10, 12,18,24 hrs;Time to first rescue analgesiaTimepoint: Up to 24 hours post-surgery;Total analgesic consumption (acetaminophen/ketorolac)Timepoint: at 24 hours

—

Countries

India

Contacts

Public ContactDr Anudeep Jafra

PGIMER CHANDIGARH

anu_gmch@yahoo.co.in9888027699

Outcome results

None listed

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