HypospadiasNCT06561269
Multifidus Plane Block Versus Caudal Block for Hypospadias
A study testing Multifidus plane block and caudal block in people with Hypospadias and Caudal Block, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to evaluate the safety and efficacy of ultrasound-guided sacral multifidus plane block and compare its analgesic effect to ultrasound-guided caudal block in pediatric patients undergoing hypospadias surgery under general anesthesia Read more about this study
- Who is it for?
- Ages 1 year to 7 years, men only
- Conditions the study is for
- Hypospadias, Caudal Block
- What is being tested?
- Multifidus plane block and caudal block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 7 Apr 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
- No healthy volunteers
- Child
Who may be able to join
- ⦁ Children aged (1 -7) years old.
- All patients will be of ASA classification I, II physical status
Who cannot join
- ⦁ Parents refusing to participate are excluded from the trial.
- Children who had spinal anomalies, altered mental status.
- A history of developmental delay.
- Blood diseases: Coagulopathy or anaemia.
- Infection at the site of injection.
- Drug allergy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound_guided Multifidus Plane Block Versus Ultrasound_guided Caudal Block for Pediatric Hypospadias Surgery: a Randomized Controlled Clinical Trial
This study aims to evaluate the safety and efficacy of ultrasound-guided sacral multifidus plane block and compare its analgesic effect to ultrasound-guided caudal block in pediatric patients undergoing hypospadias surgery under general anesthesia
Read the detailed description
Peri-operative pain management in pediatric surgeries is considered a challenging issue for the anesthesiologists. The usage of regional anesthesia in association with general anesthesia (GA) is a simple intraoperative way that reduces (GA) requirements and side effects. Recently, paraspinal fascial plane block, the sacral multifidus plane block (MPB), was used successfully in infants. The study has been designed to determine the effect of MPB versus caudal epidural block to control peri-operative pain in hypospadias surgeries in children.
- Conditions
- Hypospadias, Caudal Block
- Being tested
- Multifidus plane block, caudal block
- Keywords
- Hypospadias, caudal block
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifidus plane blockProcedure or surgery
Using the "in-plane" technique,The fascial plane between the multifidus muscle and the median sacral crests of S2 and S3, will be injected by bupivacaine.
caudal blockProcedure or surgery
The ultrasound transducer will first be placed transversely at the midline to obtain the transverse view of sacral hiatus. At this level, the ultrasound transducer is rotated 90 degrees to obtain the longitudinal view of sacral hiatus. The block needle is inserted using the "in-plane" technique.
| Study group | Role | What they receive |
|---|---|---|
| Multifidus plane block (MPB) group | Experimental | Participants will be injected bupivacaine at the fascial plane between the multifidus muscle and the median sacral crests of S2 and S3 Receives: Procedure: Multifidus plane block |
| Caudal block (CB) group | Experimental | Participants will be injected by bupivacaine, between the two sacral cornua Receives: Procedure: caudal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
is to measure the first time to rescue analgesia postoperative (24 hours).
Measure the first time to rescue analgesia post operative
Measured: 24 hours postoperative
Secondary outcomes (2)
Heart rate
measuring HR changes
Measured: start to end of surgery
Blood pressure
measuring BP changes
Measured: start to end of the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 Dec 2024
- Primary completion5 Mar 2025
- Study completion7 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Tarek, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561269
- Sponsor's protocol ID
- MD73/2024
- Status last verified
- Feb 2026
- First submitted
- 2 Jun 2024
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound_guided Multifidus Plane Block Versus Ultrasound_guided Caudal Block for Pediatric Hypospadias Surgery: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06561269
- Acronym / sponsor ID
- MD73/2024
- Conditions
- Hypospadias, Caudal Block
- Keywords
- Hypospadias, caudal block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 5 Mar 2025 (actual)
- Study completion
- 7 Apr 2025 (actual)
- First posted
- 20 Aug 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.
This study aims to evaluate the safety and efficacy of ultrasound-guided sacral multifidus plane block and compare its analgesic effect to ultrasound-guided caudal block in pediatric patients undergoing hypospadias surgery under general anesthesia
Detailed description
Peri-operative pain management in pediatric surgeries is considered a challenging issue for the anesthesiologists. The usage of regional anesthesia in association with general anesthesia (GA) is a simple intraoperative way that reduces (GA) requirements and side effects. Recently, paraspinal fascial plane block, the sacral multifidus plane block (MPB), was used successfully in infants. The study has been designed to determine the effect of MPB versus caudal epidural block to control peri-operative pain in hypospadias surgeries in children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifidus plane block (MPB) group | Experimental | Procedure: Multifidus plane blockParticipants will be injected bupivacaine at the fascial plane between the multifidus muscle and the median sacral crests of S2 and S3 |
| Caudal block (CB) group | Experimental | Procedure: caudal blockParticipants will be injected by bupivacaine, between the two sacral cornua |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ⦁ Children aged (1 -7) years old.
Key exclusion criteria (6 listed)
- ⦁ Parents refusing to participate are excluded from the trial.
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 |
|---|---|---|
| Multifidus plane blockUsing the "in-plane" technique,The fascial plane between the multifidus muscle and the median sacral crests of S2 and S3, will be injected by bupivacaine. | Procedure or surgery | Multifidus plane block (MPB) group |
| caudal blockThe ultrasound transducer will first be placed transversely at the midline to obtain the transverse view of sacral hiatus. At this level, the ultrasound transducer is rotated 90 degrees to obtain the longitudinal view of sacral hiatus. The block needle is inserted using the "in-plane" technique. | Procedure or surgery | Caudal block (CB) group |
Primary outcome
is to measure the first time to rescue analgesia postoperative (24 hours).
Time frame: 24 hours postoperative
Measure the first time to rescue analgesia post operative
2 secondary outcomes
Heart rate
Time frame: start to end of surgery
Blood pressure
Time frame: start to end of the surgery.
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 3 Mar 2026.
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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 Multifidus plane block and caudal block in people with Hypospadias and Caudal Block, run by Ain Shams University at 1 site in Egypt.
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 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: finished, as of the sponsor's last update on 3 Mar 2026. 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 Egypt. 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?
is to measure the first time to rescue analgesia postoperative (24 hours). (time frame: 24 hours postoperative). 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 3 Mar 2026.