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

NCT ID: NCT06789393

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2027-05-01

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

Detailed Description

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.

Conditions

Hypospadias Repair Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group A

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

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

Patients will receive dexmedetomidine (0.5 mcg/kg).

Bupivacaine

Intervention Type: DRUG

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

Group B

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

Group Type: PLACEBO_COMPARATOR

Bupivacaine

Intervention Type: DRUG

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

Interventions

Dexmedetomidine

Patients will receive dexmedetomidine (0.5 mcg/kg).

Intervention Type: DRUG

Bupivacaine

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• - 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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abd Almonaem Abd Alnazeer

residant doctor at Assiut university hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ahmed Abd Alnazeer, residant doctor

Role: CONTACT

ahmedelshreef1998801@gmail.com

+201128168619

Other Identifiers

B+D hypospadias repair surgery

Identifier Type: -

Identifier Source: org_study_id