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Effect of dexmedetomidine on pain relief duration after pudendal nerve block in children undergoing hypospadias surgery

Effect of dexmedetomidine as an adjuvant to bupivacaine on prolongation of postoperative analgesia following ultrasound-guided transperineal approach pudendal nerve block in pediatric hypospadias surgery: a prospective randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260515011
Enrollment
20
Registered
2026-05-15
Start date
2026-05-10
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Hypospadias Postoperative pain Pediatric anesthesia Dexmedetomidine Bupivacaine Pudendal nerve block Hypospadias Postoperative analgesia Pediatric surgery Ultrasound guided nerve block

Interventions

Pediatric patients receive ultrasound guided transperineal pudendal nerve block using bupivacaine for postoperative analgesia during hypospadias surgery.,Pediatric patients receive ultrasound guided
Active Comparator Procedure/Surgery,Experimental Procedure/Surgery
Bupivacaine pudendal block,Dexmedetomidine pudendal block

Sponsors

Queen Sirikit National Institute of Child Health
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
1 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1 Male pediatric patients undergoing hypospadias surgery, 2 Age 1 to 12 years 3 ASA physical status I and II,4 Elective surgery under general anesthesia

Exclusion criteria

Exclusion criteria: 1 Allergy to bupivacaine or dexmedetomidine, 2 Clinically significant cardiovascular disorders, including severe bradycardia, atrioventricular (AV) block, or uncontrolled hypotension, 3 Coagulopathy or bleeding disorder, 4 Local infection at injection site, 5 Neurological disease, 6 Hepatic dysfunction, 7 Renal impairment, 8 Use of analgesic medications before surgery, 9 Administration of fentanyl within 30 minutes before the end of surgery, 10 Refusal by parents or guardians

Design outcomes

Primary

MeasureTime frame
Time to first analgesia 0, 30, 60, 120 minutes, 4, 8, 12, 24 hours CHEOPS, Wong Baker FACES Pain Rating Scale

Secondary

MeasureTime frame
CHEOPS, Wong Baker FACES Pain Rating Scale 0, 30, 60, 120 minutes, 4, 8, 12, 24 hours CHEOPS, Wong Baker FACES Pain Rating Scale

Countries

Thailand

Contacts

Public ContactPalita Pornwilaikun

Department of Anesthesiology, Queen Sirikit National Institute of Child Health

palitapornwilaikun@gmail.com0943629145

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026