Complication of AnesthesiaNCT06667947
Effect of Caudal vs. Penile Block on the Incidence of Hypospadias Complications
A study testing caudal block in people with Complication of Anesthesia, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Hypospadias is one of the most common congenital malformations in male babies, affecting approximately 1 in every 200-300 live male births. This condition is characterized by an abnormal location of the urethral meatus, located on the ventral side of the penis, anywhere from the glans to the perineum. Read more about this study
- Who is it for?
- Ages 6 to 48 months, men only
- Conditions the study is for
- Complication of Anesthesia
- What is being tested?
- caudal block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jul 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 48 months
- Men only
- No healthy volunteers
- Child
Who may be able to join
- hypospadias
Who cannot join
- the patients who alder than 48 month
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dicle University
Sur, Di̇yarbakir, (507) 621-4125
About this study
Official title: Effect of Caudal vs. Penile Block on the Incidence of Hypospadias Complications Following Primary Repairs: A Randomized Controlled Trial
Hypospadias is one of the most common congenital malformations in male babies, affecting approximately 1 in every 200-300 live male births. This condition is characterized by an abnormal location of the urethral meatus, located on the ventral side of the penis, anywhere from the glans to the perineum.
Treatment of hypospadias is primarily surgical and aims at functional and cosmetic correction. However, surgery is often complex and can be associated with a significant risk of complications, such as fistula formation, wound dehiscence, urethral stricture, and dissatisfaction with cosmetic results. The search for optimal surgical techniques and postoperative management strategies that can reduce these complications continues.
Read more
Postoperative pain after penile surgery can cause agitation and anxiety in children, which can also lead to stress and tension in parents. In addition to ensuring the comfort of both children and parents, pain control reduces complications in the postoperative period and accelerates recovery. Different techniques such as local anesthesia, sedoanalgesia, general anesthesia or regional anesthesia are used in penile surgery. Caudal nerve block, a regional anesthesia technique, is widely used in pediatric infraumbilical surgeries, its anesthetic safety and effectiveness have been proven in recent years, and caudal block is generally applied safely to provide postoperative analgesia in these patients. These block applications reduce the need for analgesic and anesthetic drugs and prolong the pain-free period. At the same time, this method is easy and safe to apply. However, some anesthetic complications of caudal block have been reported in previous studies6. It has also been suggested that the use of caudal nerve block is a potential risk factor contributing to surgical complications in hypospadias surgeries. This was first reported by Kundra and his team in 2012. In the study, they noted that the fistula rate increased to 19.2% in patients receiving caudal nerve block compared to a 0% fistula rate in those receiving penile block during one-stage hypospadias repair. Since the initial findings of Kundra and his team, the use of caudal anesthesia during hypospadias repair has been a subject of ongoing debate.
Caudal nerve block, a regional anesthesia technique, is widely used in pediatric infraumbilical surgeries, and its safety and effectiveness as an anesthetic are well established. The purpose of this study was to evaluate the potential effect of caudal nerve block anesthesia on postoperative surgical outcomes in male patients aged 6-48 months undergoing hypospadias repair
- Conditions
- Complication of Anesthesia
- Being tested
- caudal block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caudal blockProcedure or surgery
Also called penile block
For the caudal block, a caudal needle was used by the same anesthesiologist after the patients were placed in the left lateral decubitus position.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Caudal Block Receives: Procedure: caudal block |
| Group 2 | Active comparator | Penile Block Receives: Procedure: caudal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
complication rate
Surgery-related complications such as wound dehiscence, fistula formation, and urethral stenosis due to the surgical procedure will be recorded.
Measured: 01.07.2023-01.03.2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start16 Jul 2023
- Primary completion1 Jan 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of AnesthesiaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fikret Salık, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667947
- Sponsor's protocol ID
- Dicle University
- Status last verified
- Oct 2024
- First submitted
- 8 Mar 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: ı will individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Caudal vs. Penile Block on the Incidence of Hypospadias Complications Following Primary Repairs: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06667947
- Acronym / sponsor ID
- Dicle University
- Conditions
- Complication of Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 16 Jul 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 31 Oct 2024 (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.
Hypospadias is one of the most common congenital malformations in male babies, affecting approximately 1 in every 200-300 live male births. This condition is characterized by an abnormal location of the urethral meatus, located on the ventral side of the penis, anywhere from the glans to the perineum.
Treatment of hypospadias is primarily surgical and aims at functional and cosmetic correction. However, surgery is often complex and can be associated with a significant risk of complications, such as fistula formation, wound dehiscence, urethral stricture, and dissatisfaction with cosmetic results. The search for optimal surgical techniques and postoperative management strategies that can reduce these complications continues.
Postoperative pain after penile surgery can cause agitation and anxiety in children, which can also lead to stress and tension in parents. In addition to ensuring the comfort of both children and parents, pain control reduces complications in the postoperative period and accelerates recovery. Different techniques such as local anesthesia, sedoanalgesia, general anesthesia or regional anesthesia are used in penile surgery. Caudal nerve block, a regional anesthesia technique, is widely used in pediatric infraumbilical surgeries, its anesthetic safety and effectiveness have been proven in recent years, and caudal block is generally applied safely to provide postoperative analgesia in these patients. These block applications reduce the need for analgesic and anesthetic drugs and prolong the pain-free period. At the same time, this method is easy and safe to apply. However, some anesthetic complications of caudal block have been reported in previous studies6. It has also been suggested that the use of caudal nerve block is a potential risk factor contributing to surgical complications in hypospadias surgeries. This was first reported by Kundra and his team in 2012. In the study, they noted that the fistula rate increased to 19.2% in patients receiving caudal nerve block compared to a 0% fistula rate in those receiving penile block during one-stage hypospadias repair. Since the initial findings of Kundra and his team, the use of caudal anesthesia during hypospadias repair has been a subject of ongoing debate.
Caudal nerve block, a regional anesthesia technique, is widely used in pediatric infraumbilical surgeries, and its safety and effectiveness as an anesthetic are well established. The purpose of this study was to evaluate the potential effect of caudal nerve block anesthesia on postoperative surgical outcomes in male patients aged 6-48 months undergoing hypospadias repair
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: caudal blockCaudal Block |
| Group 2 | Active comparator | Procedure: caudal blockPenile Block |
Who may qualify
- Ages
- 6 to 48 months
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- hypospadias
Key exclusion criteria (1 listed)
- the patients who alder than 48 month
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 |
|---|---|---|
| caudal blockAlso: penile blockFor the caudal block, a caudal needle was used by the same anesthesiologist after the patients were placed in the left lateral decubitus position. | Procedure or surgery | Group 1, Group 2 |
Primary outcome
complication rate
Time frame: 01.07.2023-01.03.2024
Surgery-related complications such as wound dehiscence, fistula formation, and urethral stenosis due to the surgical procedure will be recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: No. ı will individual participant data (IPD) available to other researchers.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing caudal block in people with Complication of Anesthesia, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complication rate (time frame: 01.07.2023-01.03.2024). 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 31 Oct 2024.