Dorsal Nerve Block in HypospiudusPhase 1NCT06500286
Dorsal Nerve Block and Caudal Block in Hypospedius Repair in Children
A Phase 1 study testing Marciane and Marcaine in people with Dorsal Nerve Block in Hypospiudus, run by Assiut University.
Trial summary
Comparison between Dorsal nerve block and caudal block effect in post operative pain in hypospedius repair in children Randomoized clinical trial Read more about this study
- Who is it for?
- Ages 2 to 12 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dorsal Nerve Block in Hypospiudus
- What is being tested?
- Marciane and Marcaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Mar 2025
- Phase
- Phase 1
- 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 2 to 12 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- aged 2-12 years
- ASA physical status I or II
Who cannot join
- asthmatic patients
- emergency surgery
- intellectual disability
- neurological diseases with agitation-like symptoms
- renal or hepatic disease,
- cardiac or respiratory disease
Show all 9Show fewer
- allergy to the study drugs
- parent refusal
- psychiatric diseases
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison Between Dorsal Nerve Block and Caudal Block Effect in Post Operative Pain in Hypospedius Repair in Children
Comparison between Dorsal nerve block and caudal block effect in post operative pain in hypospedius repair in children Randomoized clinical trial
Read the detailed description
- Group A receive caudal block placing the patient into the left lateral decubitus position. Povidone iodine was used to sterilize the skin. The sacral hiatus was found by palpating the sacral cornu and a 22-G needle was placed through it. After passing through the sacrococcygeal membrane by using the loss of resistance method, the caudal epidural space was entered. Negative aspiration was used to make sure there was no blood or cerebrospinal fluid present and 0.25% bupivacaine was administered at a dose of 0.2 ml/kg. Once the procedure was completed, the patient was placed into the supine Position.
Group B US guided Dorsal penil block. General anesthesia induction was followed by skin sterilization using 70% alcohol in 2% chlorhexidine. The 5-10 MHz linear probe was placed at the penis root, making it possible to observe the corpus cavernosum, corpus spongiosum, dorsal artery and vein, and the deep penile fascia (Buck's fascia) on the transverse plane with gentle penile traction. The in-plane technique was then used to insert a 50-mm block needle toward the dorsal penile section from the lateral part of the penis root. The needle was then advanced from the hyperechoic superficial penis fascia (Dartos fascia) and the superficial sheath was passed. After advancing the needle into Buck's fascia, the needle was placed lateral to the dorsal artery, at a position between Buck's fascia and tunica albuginea. Negative aspiration was performed. US was then used to observe the distribution of the anesthetic while half of the total 0.25% bupivacaine dose (0.2 mL/kg) was administered (Fig. 1). Afterward, the same procedure was also performed on the other side of the penis.
- Conditions
- Dorsal Nerve Block in Hypospiudus
- Being tested
- Marciane, Marcaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MarcianeDrug
Also called bupivacaine
Group A caudal block 0.25% bupivacaine was administered at a dose of 0.2 ml/k
MarcaineDrug
Also called bupivacaine
Dorsal penil block 0.25% bupivacaine was administered at a dose of 0.2 ml/k
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | • Group A receive caudal block placing the patient into the left lateral decubitus position. . The sacral hiatus was found by palpating the sacral cornu and a 22-G needle was placed through it. After passing through the sacrococcygeal 0.25% bupivacaine was administered at a dose of 0.2 ml/kg.the procedure was completed, the patient was placed into the supine Position. Receives: Drug: Marciane |
| Group B | Experimental | Group B US guided Dorsal penil block. The 5-10 MHz linear probe was placed at the penis root, making it possible to observe the corpus cavernosum, corpus spongiosum, dorsal artery and vein, and the deep penile fascia (Buck's fascia) on the transverse plane with gentle penile traction. The in-plane technique was then used to insert a 50-mm block needle toward the dorsal penile section from the lateral part of the penis root. The needle was then advanced from the hyperechoic superficial penis fascia (Dartos fascia) and the superficial sheath was passed. After advancing the needle into Buck's fascia, the needle was placed lateral to the dorsal artery, at a position between Buck's fascia and tunica albuginea. Negative aspiration was performed. US was then used to observe the distribution of the anesthetic while half of the total 0.25% bupivacaine dose (0.2 mL/kg) was administered (Fig. 1). Afterward, the same procedure was also performed on the other side of the penis. Receives: Drug: Marcaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of dorsal penile block
Score of pain visual Analougue Score
Measured: 1year
Secondary outcomes (1)
Comparison between post operative analegesia effect and side effect of dorsal penileblock and caudal block
Comparison between post operative analegesia effect and side effect of dorsal penileblock and caudal block
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dorsal Nerve Block in HypospiudusStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soha Abd Elhamid Fawzy, Assiut University
- Investigators
- Soha Abdelhamid Fawzy, Resident, Principal investigator, Resident
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500286
- Sponsor's protocol ID
- Dorsal block in hypospedius
- Status last verified
- Jul 2024
- First submitted
- 10 Mar 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baskin LS, Lee YT, Cunha GR. Neuroanatomical ontogeny of the human fetal penis. Br J Urol. 1997 Apr;79(4):628-40. doi: 10.1046/j.1464-410x.1997.00119.x.
PubMed 9126098Ngoo A, Borzi P, McBride CA, Patel B. Penile nerve block predicts higher revision surgery rate following distal hypospadias repair when compared with caudal epidural block: A consecutive cohort study. J Pediatr Urol. 2020 Aug;16(4):439.e1-439.e6. doi: 10.1016/j.jpurol.2020.05.150. Epub 2020 Jun 6.
PubMed 32636118Hueber PA, Salgado Diaz M, Chaussy Y, Franc-Guimond J, Barrieras D, Houle AM. Long-term functional outcomes after penoscrotal hypospadias repair: A retrospective comparative study of proximal TIP, Onlay, and Duckett. J Pediatr Urol. 2016 Aug;12(4):198.e1-6. doi: 10.1016/j.jpurol.2016.04.034. Epub 2016 Jun 2.
PubMed 27318548Spinoit AF, Poelaert F, Van Praet C, Groen LA, Van Laecke E, Hoebeke P. Grade of hypospadias is the only factor predicting for re-intervention after primary hypospadias repair: a multivariate analysis from a cohort of 474 patients. J Pediatr Urol. 2015 Apr;11(2):70.e1-6. doi: 10.1016/j.jpurol.2014.11.014. Epub 2015 Feb 26.
PubMed 25797860
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Dorsal Nerve Block and Caudal Block Effect in Post Operative Pain in Hypospedius Repair in Children
- ClinicalTrials.gov ID
- NCT06500286
- Acronym / sponsor ID
- Dorsal block in hypospedius
- Conditions
- Dorsal Nerve Block in Hypospiudus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 15 Jul 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.
Comparison between Dorsal nerve block and caudal block effect in post operative pain in hypospedius repair in children Randomoized clinical trial
Detailed description
- Group A receive caudal block placing the patient into the left lateral decubitus position. Povidone iodine was used to sterilize the skin. The sacral hiatus was found by palpating the sacral cornu and a 22-G needle was placed through it. After passing through the sacrococcygeal membrane by using the loss of resistance method, the caudal epidural space was entered. Negative aspiration was used to make sure there was no blood or cerebrospinal fluid present and 0.25% bupivacaine was administered at a dose of 0.2 ml/kg. Once the procedure was completed, the patient was placed into the supine Position.
Group B US guided Dorsal penil block. General anesthesia induction was followed by skin sterilization using 70% alcohol in 2% chlorhexidine. The 5-10 MHz linear probe was placed at the penis root, making it possible to observe the corpus cavernosum, corpus spongiosum, dorsal artery and vein, and the deep penile fascia (Buck's fascia) on the transverse plane with gentle penile traction. The in-plane technique was then used to insert a 50-mm block needle toward the dorsal penile section from the lateral part of the penis root. The needle was then advanced from the hyperechoic superficial penis fascia (Dartos fascia) and the superficial sheath was passed. After advancing the needle into Buck's fascia, the needle was placed lateral to the dorsal artery, at a position between Buck's fascia and tunica albuginea. Negative aspiration was performed. US was then used to observe the distribution of the anesthetic while half of the total 0.25% bupivacaine dose (0.2 mL/kg) was administered (Fig. 1). Afterward, the same procedure was also performed on the other side of the penis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Marciane• Group A receive caudal block placing the patient into the left lateral decubitus position. . The sacral hiatus was found by palpating the sacral cornu and a 22-G needle was placed through it. After passing through the sacrococcygeal 0.25% bupivacaine was administered at a dose of 0.2 ml/kg.the procedure was completed, the patient was placed into the supine Position. |
| Group B | Experimental | Drug: MarcaineGroup B US guided Dorsal penil block. The 5-10 MHz linear probe was placed at the penis root, making it possible to observe the corpus cavernosum, corpus spongiosum, dorsal artery and vein, and the deep penile fascia (Buck's fascia) on the transverse plane with gentle penile traction. The in-plane technique was then used to insert a 50-mm block needle toward the dorsal penile section from the lateral part of the penis root. The needle was then advanced from the hyperechoic superficial penis fascia (Dartos fascia) and the superficial sheath was passed. After advancing the needle into Buck's fascia, the needle was placed lateral to the dorsal artery, at a position between Buck's fascia and tunica albuginea. Negative aspiration was performed. US was then used to observe the distribution of the anesthetic while half of the total 0.25% bupivacaine dose (0.2 mL/kg) was administered (Fig. 1). Afterward, the same procedure was also performed on the other side of the penis. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- aged 2-12 years
- ASA physical status I or II
Key exclusion criteria (9 listed)
- asthmatic patients
- emergency surgery
- intellectual disability
- neurological diseases with agitation-like symptoms
- renal or hepatic disease,
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 |
|---|---|---|
| MarcianeAlso: bupivacaineGroup A caudal block 0.25% bupivacaine was administered at a dose of 0.2 ml/k | Drug | Group A |
| MarcaineAlso: bupivacaineDorsal penil block 0.25% bupivacaine was administered at a dose of 0.2 ml/k | Drug | Group B |
Primary outcome
Efficacy of dorsal penile block
Time frame: 1year
Score of pain visual Analougue Score
1 secondary outcome
Comparison between post operative analegesia effect and side effect of dorsal penileblock and caudal block
Time frame: 1year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Results publication: PubMed 9126098Baskin LS, Lee YT, Cunha GR. Neuroanatomical ontogeny of the human fetal penis. Br J Urol. 1997 Apr;79(4):628-40. doi: 10.1046/j.1464-410x.1997.00119.x.
- Results publication: PubMed 32636118Ngoo A, Borzi P, McBride CA, Patel B. Penile nerve block predicts higher revision surgery rate following distal hypospadias repair when compared with caudal epidural block: A consecutive cohort study. J Pediatr Urol. 2020 Aug;16(4):439.e1-439.e6. doi: 10.1016/j.jpurol.2020.05.150. Epub 2020 Jun 6.
- Results publication: PubMed 27318548Hueber PA, Salgado Diaz M, Chaussy Y, Franc-Guimond J, Barrieras D, Houle AM. Long-term functional outcomes after penoscrotal hypospadias repair: A retrospective comparative study of proximal TIP, Onlay, and Duckett. J Pediatr Urol. 2016 Aug;12(4):198.e1-6. doi: 10.1016/j.jpurol.2016.04.034. Epub 2016 Jun 2.
- Results publication: PubMed 25797860Spinoit AF, Poelaert F, Van Praet C, Groen LA, Van Laecke E, Hoebeke P. Grade of hypospadias is the only factor predicting for re-intervention after primary hypospadias repair: a multivariate analysis from a cohort of 474 patients. J Pediatr Urol. 2015 Apr;11(2):70.e1-6. doi: 10.1016/j.jpurol.2014.11.014. Epub 2015 Feb 26.
- Individual participant dataSharing planned: No
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.
Soha Abdelhamid Fawzy, Resident principal investigator
Resident
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Marciane and Marcaine in people with Dorsal Nerve Block in Hypospiudus, 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 2 inclusion and 9 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 15 Jul 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Soha Abdelhamid Fawzy, Resident (01061424208, sohaSoha.abd.elhamid.3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of dorsal penile block (time frame: 1year). 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 NCT06500286, which also lists 4 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 15 Jul 2024.