Effects of perineural dexmedetomidine in ultrasound-guided transperineal pudendal nerve block for pediatrics hypospadias surgery: A randomized control trial, multi-center study

Phase 3

• Conditions: hypospadias; dexmedetomidine; pudendal nerve block; postoperative pain

• Registration Number: TCTR20201203004
• Lead Sponsor: Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-03
• Study Completion: 2022-01-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Children age 1 to 7 years
2. American Society of Anesthesiologists (ASA) class I - II
3. Undergo elective hypospadias repair
4. I’m appreciate to participate in this study with sign

Exclusion Criteria

1. Refuse regional block
2. Obvious anatomical anomalies e.g. sacral or pelvic malformations 3. History of bupivacaine, dexmedetomidine, paracetamol and ibuprofen allergy
4. History of coagulopathy
5. History of renal or liver disease
6. Infection of the injection site
7. Spinal abnormality e.g. myelomeningocele or tether cord
8. Developmental disability e.g. attention deficit or cerebral palsy
9. Body Mass Index (BMI) > 30 kg/m2
10. Patients who have conduction system pathology or receiving AV nodal slowing agents
11. I can refuse or withdrawn anytime during the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of patients require analgesics in the first 24 hour Post-operative period in PACU and surgical ward the number of patients requiring both intravenous fentanyl in the PACU and oral ibuprofen at the sur