Comparison of the Efficacy of Bupivacaine with and Without Dexmedetomidine As an Adjuvant on Penile Block for Postoperative Pain Relief in Pediatrics Undergoing Hypospadias Repair Surgery

NCT06789393 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: B+D hypospadias repair surgery
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main issue with pain management in children especially young children is the difficulty involved in evaluating it. When a patient's level of pain cannot be accurately assessed, effective analgesia cannot be prescribed. When children are not sufficiently treated for pain, stress hormones are released into their systems, resulting in increased catabolism, immunosuppression and hemodynamic instability . Peripheral nerve blocks may be favored over neuroaxial blocks because they allow quicker mobilization after surgery. Hypospadias results from abnormal development of the penis that leaves the urethral meatus proximal to its normal glanular position anywhere along the penile shaft, scrotum, or perineum. A spectrum of abnormalities, including ventral curvature of the penis (chordee), a hooded incomplete prepuce, and an abortive corpora spongiosum, are commonly associated with hypospadias. Surgical correction is typically performed during early childhood to restore normal appearance and function. Penile block is a widely used regional anesthesia technique for hypospadias repair, It involves the administration of a local anesthetic around the penile nerve, providing effective pain relief during and after surgery. While effective, the duration of analgesia provided by a penile block with local anesthetics alone is often limited, necessitating the use of additional analgesics in the postoperative period. Dexmedetomidine is a highly selective alpha-2 adrenergic agonist with sedative, anxiolytic, and analgesic properties. It has been increasingly used as an adjuvant in regional anesthesia to prolong the duration of analgesia and reduce opioid consumption . The addition of dexmedetomidine to local anesthetics has been shown to enhance the quality and duration of nerve blocks in various surgical settings but its efficacy in penile block for pediatric hypospadias repair has not been extensively studied. the aim of the study To assess the duration of analgesia provided by the penile block with dexmedetomidine. Timing and episodes of rescue analgesia consumption . To monitor and report any adverse effects associated with the use of dexmedetomidine such as hypotension and bradycardia

Conditions

Hypospadias Repair Surgery

Keywords

penile block

Outcome Measures

Primary Outcomes (1)

• FLACC Pain score

  FLACC Pain score (Face,Leg,Activity,Cry,Consolability) in pediatric patients undergoing hypospadias repair(post-operative). A total score between 0 and 10 It will be measured at the recovery room and 2,6,12,24 hours posoprtatively

  24 hours

Study Arms (2)

Group A

ACTIVE COMPARATOR

Penile block with bupivacaine 0.25% (0.2 ml/kg) plus dexmedetomidine (0.5 mcg/kg)

Drug: Dexmedetomidine; Drug: Bupivacaine

Group B

PLACEBO COMPARATOR

Penile block with bupivacaine 0.25% (0.2 ml/kg) only

Drug: Bupivacaine

Interventions

Dexmedetomidine DRUG

Patients will receive dexmedetomidine (0.5 mcg/kg).

Group A

Bupivacaine DRUG

Penile block with bupivacaine 0.25% (0.2 ml/kg)

Group A; Group B

Eligibility Criteria

• Age: 6 Months - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6 months to 7 years
• Scheduled for primary hypospadias repair under general anesthesia
• Parental consent obtained

You may not qualify if:

• \- Known allergy to dexmedetomidine or other study medications .
• History of cardiovascular or respiratory disease.
• Active infection.
• History of developmental or mental retardation .
• Coagulation disorders.
• Parental refusal.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Dexmedetomidine; Bupivacaine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Ahmed Abd Alnazeer, residant doctor

CONTACT

+201128168619; ahmedelshreef1998801@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: residant doctor at Assiut university hospital

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 23, 2025

Record last verified: 2025-01