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

January 17, 2025 updated by: Ahmed Abd Almonaem Abd Alnazeer, Assiut University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Penile block with bupivacaine 0.25% (0.2 ml/kg) plus dexmedetomidine (0.5 mcg/kg)
Drug: Dexmedetomidine
Patients will receive dexmedetomidine (0.5 mcg/kg).
Drug: Bupivacaine
Penile block with bupivacaine 0.25% (0.2 ml/kg)
Placebo Comparator: Group B
Penile block with bupivacaine 0.25% (0.2 ml/kg) only
Drug: Bupivacaine
Penile block with bupivacaine 0.25% (0.2 ml/kg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FLACC Pain score
Time Frame: 24 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

January 17, 2025

First Submitted That Met QC Criteria

January 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 17, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B+D hypospadias repair surgery

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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