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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 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-01-23

No results posted yet for this study

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

Interventions

DRUG

Dexmedetomidine

Patients will receive dexmedetomidine (0.5 mcg/kg).

DRUG

Bupivacaine

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

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2026-03-01
Completion
2027-05-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06789393 on ClinicalTrials.gov