HypospadiasNCT06410482
Analgesia in Pediatric Hypospadias Surgeries
A study testing US guided caudal block and Dorsal penile nerve block in people with Hypospadias, run by Assiut University.
Trial summary
The primary aim of the current study will be to use the duration until the first postoperative analgesic requirement after two different block techniques to compare the analgesic effect. Read more about this study
- Who is it for?
- Ages 1 year to 7 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypospadias
- What is being tested?
- US guided caudal block and Dorsal penile nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Jun 2025
- 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 1 year to 7 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- • Children aged 1-7 years old
- ASA I and II
- Children scheduled for primary hypospadias repair
Who cannot join
- • Patient's guardian refusal to participate in the study.
- Children with Behavioural changes; physical or developmental delay; neurological disorder or psychological disorder.
- Children on sedative or anticonvulsant medication.
- Bleeding diathesis
- Infection of injecting area
- significant organ dysfunction, cardiac, liver or mental retardation.
- Congenital low back anomaly.
- Known allergy to the study drugs
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison Between the Analgesic Efficacy of the Ultrasound Penile Block Versus Ultrasound Caudal Epidural for Pediatric Hypospadias Surgeries: A Prospective Randomized Double Blinded Trial
The primary aim of the current study will be to use the duration until the first postoperative analgesic requirement after two different block techniques to compare the analgesic effect.
The secondary aims will be to compare the two methods for postoperative Children's Hospital Eastern Ontario Pain Scale (CHEOPS) scores, complications and parental satisfaction scores.
Read the detailed description
Hypospadias, seen in every 200-300 births, is one of the most common congenital anomalies of the penis and is defined as the urethral meatus being located in the ventral part of the penis instead of its normal place.
Although current guidelines propose an optimal age for hypospadias repair of 6-18 months , patient ages vary widely, from infants to adults, in daily practice. According to the literature, hypospadias surgery can be performed in a wide age range of 6 months-12 years. The age of the patients undergoing hypospadias surgery in our country can vary between 1 and 10 years. The surgery of this anomaly is very painful in the postoperative period and requires long-term analgesia. Regional anesthesia methods combined with general anesthesia play an important role in providing effective and long-term postoperative pain control in pediatric penile surgery. These methods also reduce postoperative morbidity, enable early mobilization and significantly decrease the need for narcotic analgesics.
A dorsal penile nerve block (DPNB) and caudal epidural block (CEB) are commonly used regional anesthesia techniques for postoperative pain control in hypospadias repair. CEB is the more commonly used neuraxial block method for providing effective postoperative analgesia in lower abdominal, urogenital and lower extremity surgical operations in pediatric patients. However, it has recently been suggested in the literature that peripheral nerve blocks should be preferred to neuraxial blocks as they provide longer-term analgesia and have fewer side effects. DPNB is a peripheral nerve block method that has been widely used for various penile operations since it will be first defined in the mid-1970s. This method is mostly used with the landmark technique. It will be first used by Sandeman et al via the out-of-plane technique with ultrasound (US) and will be reported to provide effective analgesia in the postoperative period. Suleman et al described DPNB for the first time with the in-plane technique, indicating that the tissue and neurovascular structures of the penis could be better distinguished in the transverse plane in ultrasound (US). A limited number of studies have shown the technique to provide more effective and longer term postoperative analgesia compared to the landmark technique and CEB.
- Conditions
- Hypospadias
- Being tested
- US guided caudal block, Dorsal penile nerve block
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US guided caudal blockProcedure or surgery
After placing the patient in the left lateral position (hips and knees flexed) following monitoring and induction of anaesthesia, the field will be sterilized with 70% alcohol in 2% chlorhexidine.
Initial scanning in the transverse plane allows for visualization of the midline and identification of the sacrococcygeal ligament between the 2 sacral cornua. The 2 cornua resemble the 2 eyes of a frog and thus are collectively called the frog-eye sign. The US probe is then rotated 90 degrees to acquire a longitudinal view. The needle is then advanced at a 20-degree angle with needle tip and length visualization Once the needle is confirmed to be in the caudal space on the screen, carefully aspirate to confirm absence of CSF or blood.
A slow injection of the local anaesthetic can then be performed, dose of (0.2 mL/kg 0.25% bupivacaine and 1 μg/kg of dexmedetomidine
Dorsal penile nerve blockProcedure or surgery
after general anesthesia induction. With the patient in the supine position. After skin sterilization the US linear probe will be transversely placed on the root of the penis. After placing the penis in gentle traction, a50 mm block needle will be inserted from the lateral part of the penis root towards the dorsal section of the penis with the in-plane technique, It will be advanced through Dartos fascia until resistance to the needle disappeared.
Once the superficial sheath will be passed, the tip of the needle will be advanced into Buck's fascia and then positioned between Buck's fascia and tunica albuginea, lateral to the dorsal artery. After making sure there will be no blood with negative aspiration, half of the total 0.2 mL/kg dose of 0.25% bupivacaine will be administered while observing its distribution with US. The same procedure will be then repeated on the other side of the penis.
| Study group | Role | What they receive |
|---|---|---|
| US guided caudal block Anesthesia | Experimental | Children will receive caudal block analgesia Receives: Procedure: US guided caudal block |
| Dorsal penile nerve block Anesthesia | Active comparator | Children will receive Penile block analgesia Receives: Procedure: Dorsal penile nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain and analgesic requirement after two different block techniques to compare the analgesic effect.
Postoperative pain will be assessed using the Children's Hospital Eastern Ontario Pain Scale (CHEOPS) score at 30 minutes, 1, 2, 6, 12 and 24 hours.
the minimum score is 4 (better outcome) and the maximum score is 13 (worse outcome). A score ≥ 5 should be considered sufficient to administer an analgesic to the child, where a score of ≥ 8 makes it a requirement to administer an analgesic to the child.
Measured: 24 hours after the end of surgery
Secondary outcomes (2)
Postoperative complications
Postoperative complications as nausea, vomiting, urinary retention, lower limb numbness, motor block, and ecchymosis or hematoma at site of injection will be recorded.
Measured: 24 hours after the end of surgery
Postoperative Parental satisfaction
Parental satisfaction score will be determined 24 h after the surgery by an anesthetist blinded to the study groups. The child's comfort, activity level and the presence or absence of pain will be used to determine the result as 1 (unsatisfied), 2 (satisfied or good), or 3 (very satisfied or excellent)
Measured: 24 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study startMay 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypospadiasStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Gaafer, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410482
- Sponsor's protocol ID
- pediatric hypospadias
- Status last verified
- May 2024
- First submitted
- 14 Nov 2023
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kendigelen P, Tutuncu AC, Emre S, Altindas F, Kaya G. Pudendal Versus Caudal Block in Children Undergoing Hypospadias Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):610-5. doi: 10.1097/AAP.0000000000000447.
PubMed 27501015Yigit D, Ozen V, Kandirici A, Dokucu AI. Ultrasound-guided dorsal penile nerve block is a safe block in hypospadias surgery: A retrospective clinical study. Medicine (Baltimore). 2022 Jul 1;101(26):e29700. doi: 10.1097/MD.0000000000029700.
PubMed 35777019
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Analgesic Efficacy of the Ultrasound Penile Block Versus Ultrasound Caudal Epidural for Pediatric Hypospadias Surgeries: A Prospective Randomized Double Blinded Trial
- ClinicalTrials.gov ID
- NCT06410482
- Acronym / sponsor ID
- pediatric hypospadias
- Conditions
- Hypospadias
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 13 May 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.
The primary aim of the current study will be to use the duration until the first postoperative analgesic requirement after two different block techniques to compare the analgesic effect.
The secondary aims will be to compare the two methods for postoperative Children's Hospital Eastern Ontario Pain Scale (CHEOPS) scores, complications and parental satisfaction scores.
Detailed description
Hypospadias, seen in every 200-300 births, is one of the most common congenital anomalies of the penis and is defined as the urethral meatus being located in the ventral part of the penis instead of its normal place.
Although current guidelines propose an optimal age for hypospadias repair of 6-18 months , patient ages vary widely, from infants to adults, in daily practice. According to the literature, hypospadias surgery can be performed in a wide age range of 6 months-12 years. The age of the patients undergoing hypospadias surgery in our country can vary between 1 and 10 years. The surgery of this anomaly is very painful in the postoperative period and requires long-term analgesia. Regional anesthesia methods combined with general anesthesia play an important role in providing effective and long-term postoperative pain control in pediatric penile surgery. These methods also reduce postoperative morbidity, enable early mobilization and significantly decrease the need for narcotic analgesics.
A dorsal penile nerve block (DPNB) and caudal epidural block (CEB) are commonly used regional anesthesia techniques for postoperative pain control in hypospadias repair. CEB is the more commonly used neuraxial block method for providing effective postoperative analgesia in lower abdominal, urogenital and lower extremity surgical operations in pediatric patients. However, it has recently been suggested in the literature that peripheral nerve blocks should be preferred to neuraxial blocks as they provide longer-term analgesia and have fewer side effects. DPNB is a peripheral nerve block method that has been widely used for various penile operations since it will be first defined in the mid-1970s. This method is mostly used with the landmark technique. It will be first used by Sandeman et al via the out-of-plane technique with ultrasound (US) and will be reported to provide effective analgesia in the postoperative period. Suleman et al described DPNB for the first time with the in-plane technique, indicating that the tissue and neurovascular structures of the penis could be better distinguished in the transverse plane in ultrasound (US). A limited number of studies have shown the technique to provide more effective and longer term postoperative analgesia compared to the landmark technique and CEB.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US guided caudal block Anesthesia | Experimental | Procedure: US guided caudal blockChildren will receive caudal block analgesia |
| Dorsal penile nerve block Anesthesia | Active comparator | Procedure: Dorsal penile nerve blockChildren will receive Penile block analgesia |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- • Children aged 1-7 years old
Key exclusion criteria (8 listed)
- • Patient's guardian refusal to participate in the study.
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 |
|---|---|---|
| US guided caudal blockAfter placing the patient in the left lateral position (hips and knees flexed) following monitoring and induction of anaesthesia, the field will be sterilized with 70% alcohol in 2% chlorhexidine. Initial scanning in the transverse plane allows for visualization of the midline and identification of the sacrococcygeal ligament between the 2 sacral cornua. The 2 cornua resemble the 2 eyes of a frog and thus are collectively called the frog-eye sign. The US probe is then rotated 90 degrees to acquire a longitudinal view. The needle is then advanced at a 20-degree angle with needle tip and length visualization Once the needle is confirmed to be in the caudal space on the screen, carefully aspirate to confirm absence of CSF or blood. A slow injection of the local anaesthetic can then be performed, dose of (0.2 mL/kg 0.25% bupivacaine and 1 μg/kg of dexmedetomidine | Procedure or surgery | US guided caudal block Anesthesia |
| Dorsal penile nerve blockafter general anesthesia induction. With the patient in the supine position. After skin sterilization the US linear probe will be transversely placed on the root of the penis. After placing the penis in gentle traction, a50 mm block needle will be inserted from the lateral part of the penis root towards the dorsal section of the penis with the in-plane technique, It will be advanced through Dartos fascia until resistance to the needle disappeared. Once the superficial sheath will be passed, the tip of the needle will be advanced into Buck's fascia and then positioned between Buck's fascia and tunica albuginea, lateral to the dorsal artery. After making sure there will be no blood with negative aspiration, half of the total 0.2 mL/kg dose of 0.25% bupivacaine will be administered while observing its distribution with US. The same procedure will be then repeated on the other side of the penis. | Procedure or surgery | Dorsal penile nerve block Anesthesia |
Primary outcome
postoperative pain and analgesic requirement after two different block techniques to compare the analgesic effect.
Time frame: 24 hours after the end of surgery
Postoperative pain will be assessed using the Children's Hospital Eastern Ontario Pain Scale (CHEOPS) score at 30 minutes, 1, 2, 6, 12 and 24 hours. the minimum score is 4 (better outcome) and the maximum score is 13 (worse outcome). A score ≥ 5 should be considered sufficient to administer an analgesic to the child, where a score of ≥ 8 makes it a requirement to administer an analgesic to the child.
2 secondary outcomes
Postoperative complications
Time frame: 24 hours after the end of surgery
Postoperative Parental satisfaction
Time frame: 24 hours post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Background: PubMed 27501015Kendigelen P, Tutuncu AC, Emre S, Altindas F, Kaya G. Pudendal Versus Caudal Block in Children Undergoing Hypospadias Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):610-5. doi: 10.1097/AAP.0000000000000447.
- Background: PubMed 35777019Yigit D, Ozen V, Kandirici A, Dokucu AI. Ultrasound-guided dorsal penile nerve block is a safe block in hypospadias surgery: A retrospective clinical study. Medicine (Baltimore). 2022 Jul 1;101(26):e29700. doi: 10.1097/MD.0000000000029700.
Related trials for Hypospadias
Not yet recruitingPhase 4
Effect of Oxybutynin on Opioid Use After Urologic Surgery in Children
Ureteropelvic Junction Obstruction, Hypospadias
Recruiting
Worldwide Yearly Screening for Hypospadias
Hypospadias
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Active, not recruiting
Evaluating the Efficacy and Safety of Tranexamic Acid in Reducing Perioperative Bleeding During Recurrent Hypospadias Repair.
Perioperative Bleeding During Recurrent Hypospadias Repair
Not yet recruiting
Efficacy of PRF in Hypospadias Repair
Hypospadias
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.
Questions about this trial
What is this clinical trial studying?
A study testing US guided caudal block and Dorsal penile nerve block in people with Hypospadias, 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 8 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: status not confirmed, as of the sponsor's last update on 13 May 2024. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esraa Gaafer, Resident (+201156063201, esraa.gaafer10@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain and analgesic requirement after two different block techniques to compare the analgesic effect. (time frame: 24 hours after the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06410482, which also lists 2 linked publications.
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 13 May 2024.