Hypospadias Repair SurgeryPhase 3NCT06789393
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
A Phase 3 study testing Dexmedetomidine and Bupivacaine in people with Hypospadias Repair Surgery, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 7 years
- Conditions the study is for
- Hypospadias Repair Surgery
- What is being tested?
- Dexmedetomidine and Bupivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6 months to 7 years
- Scheduled for primary hypospadias repair under general anesthesia
- Parental consent obtained
Who cannot join
- - 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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
Read the 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
- Being tested
- Dexmedetomidine, Bupivacaine
- Keywords
- penile block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Patients will receive dexmedetomidine (0.5 mcg/kg).
BupivacaineDrug
Penile block with bupivacaine 0.25% (0.2 ml/kg)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Penile block with bupivacaine 0.25% (0.2 ml/kg) plus dexmedetomidine (0.5 mcg/kg) Receives: Drug: Dexmedetomidine; Drug: Bupivacaine |
| Group B | Placebo comparator | Penile block with bupivacaine 0.25% (0.2 ml/kg) only Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypospadias Repair SurgeryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abd Almonaem Abd Alnazeer, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789393
- Sponsor's protocol ID
- B+D hypospadias repair surgery
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2025
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06789393
- Acronym / sponsor ID
- B+D hypospadias repair surgery
- Conditions
- Hypospadias Repair Surgery
- Keywords
- penile block
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Dexmedetomidine, Drug: BupivacainePenile block with bupivacaine 0.25% (0.2 ml/kg) plus dexmedetomidine (0.5 mcg/kg) |
| Group B | Placebo comparator | Drug: BupivacainePenile block with bupivacaine 0.25% (0.2 ml/kg) only |
Who may qualify
- Ages
- 6 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 6 months to 7 years
- Scheduled for primary hypospadias repair under general anesthesia
- Parental consent obtained
Key exclusion criteria (6 listed)
- - Known allergy to dexmedetomidine or other study medications .
- History of cardiovascular or respiratory disease.
- Active infection.
- History of developmental or mental retardation .
- Coagulation disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidinePatients will receive dexmedetomidine (0.5 mcg/kg). | Drug | Group A |
| BupivacainePenile block with bupivacaine 0.25% (0.2 ml/kg) | Drug | Group A, Group B |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Urethral Mobilisation Versus Mathieu Technique for Repair of Distal Hypospadias
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine and Bupivacaine in people with Hypospadias Repair Surgery, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Abd Alnazeer, residant doctor (+201128168619, ahmedelshreef1998801@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FLACC Pain score (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.