HypospadiasNCT07099560
Ultrasound Guided Sacral Erector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric Undergoing Hypospadias Surgery
A study testing Ultrasound-guided sacral erector spinae plane block (sESPB) and Ultrasound-guided caudal epidural block in people with Hypospadias and Caudal Block, run by Tanta University at 1 site in Egypt.
Trial summary
Randomized, parallel-group, assessor-blinded clinical trial at Tanta University Hospitals comparing ultrasound-guided sacral erector spinae plane block (sESPB) versus ultrasound-guided caudal epidural block for postoperative analgesia in male children (1-5 years) undergoing hypospadias repair. Read more about this study
- Who is it for?
- Ages 1 year to 5 years, men only
- Conditions the study is for
- Hypospadias, Caudal Block, Erector Spinae Plane Block
- What is being tested?
- Ultrasound-guided sacral erector spinae plane block (sESPB) and Ultrasound-guided caudal epidural block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to Apr 2026
- Phase
- Interventional
- 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 1 year to 5 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Male children aged 1-5 years
- ASA physical status I-II
- Scheduled for elective hypospadias repair under general anesthesia
- Parent or legal guardian provides written informed consent
- Able to complete postoperative assessments through 24 hours after surgery Exclusion Criteria
- Parent/guardian refusal of participation
Show all 12Show fewer
- Coagulopathy or current anticoagulant therapy
- Infection at the intended injection site (sacral/caudal region) or systemic infection
- Allergy/hypersensitivity to amide local anesthetics (e.g., bupivacaine) or study medications
- Neurologic or spinal disorders or congenital sacral anomalies affecting block safety
- Significant hepatic, renal, or cardiac disease
- Any other condition that, in the investigator's judgment, contraindicates caudal block or sacral ESPB or could interfere with safe participation
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospital
Tanta, El-Gharbia Govenorate, 31527
Marwa A ELoraby, MD
Gehan M Eid, MD
About this study
Official title: Comparison of Preemptive Analgesic Effect of Ultrasound Guided Sacral Erector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric Undergoing Hypospadias Surgery
Randomized, parallel-group, assessor-blinded clinical trial at Tanta University Hospitals comparing ultrasound-guided sacral erector spinae plane block (sESPB) versus ultrasound-guided caudal epidural block for postoperative analgesia in male children (1-5 years) undergoing hypospadias repair. Seventy participants will be randomized 1:1 to receive sESPB or caudal block with 0.25% bupivacaine (0.5-1 mL/kg; maximum 20 mL) after induction of general anesthesia. The primary outcome is pain over the first 24 hours, assessed using the FLACC scale at prespecified time points. Secondary outcomes include total opioid consumption, time to first rescue analgesia, postoperative nausea and vomiting, parent/guardian satisfaction, hemodynamic trends, and predefined adverse effects (e.g., motor weakness, urinary retention, respiratory depression, hematoma, infection at injection site). Perioperative care is standardized; rescue pethidine is administered when FLACC ≥4. The trial evaluates whether sESPB provides superior or comparable analgesia with fewer adverse effects than caudal block.
Read the detailed description
Randomized, parallel-group, assessor-blinded clinical trial at Tanta University Hospitals comparing ultrasound-guided sacral erector spinae plane block (sESPB) versus ultrasound-guided caudal epidural block for postoperative analgesia in male children (1-5 years) undergoing hypospadias repair. Seventy participants will be randomized 1:1 to receive sESPB or caudal block with 0.25% bupivacaine (0.5-1 mL/kg; maximum 20 mL) after induction of general anesthesia. The primary outcome is pain over the first 24 hours, assessed using the FLACC scale at prespecified time points. Secondary outcomes include total opioid consumption, time to first rescue analgesia, postoperative nausea and vomiting, parent/guardian satisfaction, hemodynamic trends, and predefined adverse effects (e.g., motor weakness, urinary retention, respiratory depression, hematoma, infection at injection site). Perioperative care is standardized; rescue pethidine is administered when FLACC ≥4. The trial evaluates whether sESPB provides superior or comparable analgesia with fewer adverse effects than caudal block.
- Being tested
- Ultrasound-guided sacral erector spinae plane block (sESPB), Ultrasound-guided caudal epidural block
- Keywords
- hypospadias, nerve block, erector spinae plane block, caudal block, pain, ultra-sound
- Medical subject headings
- Hypospadias, Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided sacral erector spinae plane block (sESPB)Procedure or surgery
Also called sESPB, sacral ESP block
After induction of general anesthesia, bilateral sESPB is performed under ultrasound guidance. Needle advanced to the sacral interfascial plane near the median sacral crest; after negative aspiration, bupivacaine 0.25% at 0.5-1 mL/kg (max total 20 mL) is injected. Standardized perioperative care; rescue pethidine 0.5 mg/kg if FLACC ≥4.
Ultrasound-guided caudal epidural blockProcedure or surgery
Also called Caudal epidural block (CEB), Caudal epidural anesthesia, Caudal block
After induction of general anesthesia, caudal epidural injection via sacral hiatus under ultrasound guidance; after negative aspiration, bupivacaine 0.25% at 0.5-1 mL/kg (max total 20 mL) is injected. Standardized perioperative care; rescue pethidine if FLACC ≥4.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Sacral Erector Spinae Plane Block (sESPB) | Experimental | Participants receive bilateral ultrasound-guided sacral ESPB after induction of general anesthesia. Using a high-frequency linear probe, the needle is advanced to the sacral fascial plane near the median sacral crest; after negative aspiration, bupivacaine 0.25% at 0.5-1 mL/kg (maximum total volume 20 mL) is injected. Standardized perioperative care; rescue analgesia (pethidine 0.5 mg/kg) if FLACC ≥4. Receives: Procedure: Ultrasound-guided sacral erector spinae plane block (sESPB) |
| Arm B - Active Comparator: Caudal Epidural Block | Experimental | Participants receive ultrasound-guided caudal epidural block after induction of general anesthesia. Needle introduced via the sacral hiatus under ultrasound; after negative aspiration, bupivacaine 0.25% at 0.5-1 mL/kg (maximum total volume 20 mL) is injected. Standardized perioperative care; rescue pethidine if FLACC ≥4. Receives: Procedure: Ultrasound-guided caudal epidural block |
What is being measured
The primary outcome is the main question the study is designed to answer.
FLACC pain score (0-10) during the first 24 hours after surgery
The FLACC scale (Face, Legs, Activity, Cry, Consolability) is a validated behavioral pain measure. Each category is scored 0-2; the total score ranges 0-10 with higher scores indicating more pain. Scores will be recorded at rest by a blinded outcomes assessor at the prespecified time points. Rescue analgesia is IV pethidine 0.5 mg/kg when FLACC ≥4. The primary analysis compares groups across time (mixed-effects model) and/or as the time-weighted mean over 0-24 h.
Measured: From immediately after surgery through 24 hours postoperatively: at the time of Post-Anesthesia Care Unit (PACU) arrival (0 hours), and at 30 minutes, 2 hours, 4 hours, 6 hours, 12 hours, and 24 hours after surgery.
Secondary outcomes (4)
Total opioid consumption (pethidine), 0-24 h (mg/kg)
Cumulative dose of IV pethidine given as rescue analgesia when FLACC ≥4, from PACU arrival through 24 h post-op. Sum all doses per participant; no other opioids planned. Group summaries will be reported.
Measured: From the time of arrival to the Post-Anesthesia Care Unit (0 hours) through 24 hours after surgery.
Time to first rescue analgesia requirement postoperatively
If FLACC pain score ≥ 4 I.V pethidine 0.5 mg/kg will be given as rescue analgesia.
Measured: From the time of arrival to the Post-Anesthesia Care Unit (0 hours) until the first rescue dose, within 24 hours after surgery
Parent's satisfaction
Parent's Satisfaction Level were recorded on a numerical scale from 1 to 3 (not satisfied - neutral - satisfied).
Measured: 24 hours postoperatively
Incidence of postoperative adverse events
Postoperative adverse events as nausea and vomiting, motor weakness, urinary retention, drowsiness, respiratory depression, hematoma or infection at the site of injection will be recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Apr 2025
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
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 Tanta 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
- Model description
- Two-arm, parallel assignment. Participants are randomized 1:1 after induction of anesthesia to receive either ultrasound-guided sacral erector spinae plane block or ultrasound-guided caudal epidural block. Each participant receives one procedure only (no crossover), and both groups are followed concurrently for 24 hours with standardized perioperative care. Randomization uses a computer-generated sequence with allocation concealment via sequentially numbered, opaque, sealed envelopes. Blocks are performed by an anesthesiologist not involved in postoperative assessments; outcome assessors are blinded to group assignment. Single-center study at Tanta University Hospitals.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Magdy Ahmed Elfekey, Tanta University
- Investigators
- Ghada MA Elfekey, MBBCH, Principal investigator, Faculty of Medicine, Tanta University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099560
- Sponsor's protocol ID
- 36264MS869/3/25
- Status last verified
- Jul 2025
- First submitted
- 25 Jul 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Preemptive Analgesic Effect of Ultrasound Guided Sacral Erector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric Undergoing Hypospadias Surgery
- ClinicalTrials.gov ID
- NCT07099560
- Acronym / sponsor ID
- 36264MS869/3/25
- Keywords
- hypospadias, nerve block, erector spinae plane block, caudal block, pain, ultra-sound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 1 Aug 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.
Randomized, parallel-group, assessor-blinded clinical trial at Tanta University Hospitals comparing ultrasound-guided sacral erector spinae plane block (sESPB) versus ultrasound-guided caudal epidural block for postoperative analgesia in male children (1-5 years) undergoing hypospadias repair. Seventy participants will be randomized 1:1 to receive sESPB or caudal block with 0.25% bupivacaine (0.5-1 mL/kg; maximum 20 mL) after induction of general anesthesia. The primary outcome is pain over the first 24 hours, assessed using the FLACC scale at prespecified time points. Secondary outcomes include total opioid consumption, time to first rescue analgesia, postoperative nausea and vomiting, parent/guardian satisfaction, hemodynamic trends, and predefined adverse effects (e.g., motor weakness, urinary retention, respiratory depression, hematoma, infection at injection site). Perioperative care is standardized; rescue pethidine is administered when FLACC ≥4. The trial evaluates whether sESPB provides superior or comparable analgesia with fewer adverse effects than caudal block.
Detailed description
Randomized, parallel-group, assessor-blinded clinical trial at Tanta University Hospitals comparing ultrasound-guided sacral erector spinae plane block (sESPB) versus ultrasound-guided caudal epidural block for postoperative analgesia in male children (1-5 years) undergoing hypospadias repair. Seventy participants will be randomized 1:1 to receive sESPB or caudal block with 0.25% bupivacaine (0.5-1 mL/kg; maximum 20 mL) after induction of general anesthesia. The primary outcome is pain over the first 24 hours, assessed using the FLACC scale at prespecified time points. Secondary outcomes include total opioid consumption, time to first rescue analgesia, postoperative nausea and vomiting, parent/guardian satisfaction, hemodynamic trends, and predefined adverse effects (e.g., motor weakness, urinary retention, respiratory depression, hematoma, infection at injection site). Perioperative care is standardized; rescue pethidine is administered when FLACC ≥4. The trial evaluates whether sESPB provides superior or comparable analgesia with fewer adverse effects than caudal block.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, parallel assignment. Participants are randomized 1:1 after induction of anesthesia to receive either ultrasound-guided sacral erector spinae plane block or ultrasound-guided caudal epidural block. Each participant receives one procedure only (no crossover), and both groups are followed concurrently for 24 hours with standardized perioperative care. Randomization uses a computer-generated sequence with allocation concealment via sequentially numbered, opaque, sealed envelopes. Blocks are performed by an anesthesiologist not involved in postoperative assessments; outcome assessors are blinded to group assignment. Single-center study at Tanta University Hospitals.
| Arm | Type | Receives |
|---|---|---|
| Arm A: Sacral Erector Spinae Plane Block (sESPB) | Experimental | Procedure: Ultrasound-guided sacral erector spinae plane block (sESPB)Participants receive bilateral ultrasound-guided sacral ESPB after induction of general anesthesia. Using a high-frequency linear probe, the needle is advanced to the sacral fascial plane near the median sacral crest; after negative aspiration, bupivacaine 0.25% at 0.5-1 mL/kg (maximum total volume 20 mL) is injected. Standardized perioperative care; rescue analgesia (pethidine 0.5 mg/kg) if FLACC ≥4. |
| Arm B - Active Comparator: Caudal Epidural Block | Experimental | Procedure: Ultrasound-guided caudal epidural blockParticipants receive ultrasound-guided caudal epidural block after induction of general anesthesia. Needle introduced via the sacral hiatus under ultrasound; after negative aspiration, bupivacaine 0.25% at 0.5-1 mL/kg (maximum total volume 20 mL) is injected. Standardized perioperative care; rescue pethidine if FLACC ≥4. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Male children aged 1-5 years
- ASA physical status I-II
- Scheduled for elective hypospadias repair under general anesthesia
- Parent or legal guardian provides written informed consent
- Able to complete postoperative assessments through 24 hours after surgery Exclusion Criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Ultrasound-guided sacral erector spinae plane block (sESPB)Also: sESPB, sacral ESP blockAfter induction of general anesthesia, bilateral sESPB is performed under ultrasound guidance. Needle advanced to the sacral interfascial plane near the median sacral crest; after negative aspiration, bupivacaine 0.25% at 0.5-1 mL/kg (max total 20 mL) is injected. Standardized perioperative care; rescue pethidine 0.5 mg/kg if FLACC ≥4. | Procedure or surgery | Arm A: Sacral Erector Spinae Plane Block (sESPB) |
| Ultrasound-guided caudal epidural blockAlso: Caudal epidural block (CEB), Caudal epidural anesthesia, Caudal blockAfter induction of general anesthesia, caudal epidural injection via sacral hiatus under ultrasound guidance; after negative aspiration, bupivacaine 0.25% at 0.5-1 mL/kg (max total 20 mL) is injected. Standardized perioperative care; rescue pethidine if FLACC ≥4. | Procedure or surgery | Arm B - Active Comparator: Caudal Epidural Block |
Primary outcome
FLACC pain score (0-10) during the first 24 hours after surgery
Time frame: From immediately after surgery through 24 hours postoperatively: at the time of Post-Anesthesia Care Unit (PACU) arrival (0 hours), and at 30 minutes, 2 hours, 4 hours, 6 hours, 12 hours, and 24 hours after surgery.
The FLACC scale (Face, Legs, Activity, Cry, Consolability) is a validated behavioral pain measure. Each category is scored 0-2; the total score ranges 0-10 with higher scores indicating more pain. Scores will be recorded at rest by a blinded outcomes assessor at the prespecified time points. Rescue analgesia is IV pethidine 0.5 mg/kg when FLACC ≥4. The primary analysis compares groups across time (mixed-effects model) and/or as the time-weighted mean over 0-24 h.
4 secondary outcomes
Total opioid consumption (pethidine), 0-24 h (mg/kg)
Time frame: From the time of arrival to the Post-Anesthesia Care Unit (0 hours) through 24 hours after surgery.
Time to first rescue analgesia requirement postoperatively
Time frame: From the time of arrival to the Post-Anesthesia Care Unit (0 hours) until the first rescue dose, within 24 hours after surgery
Parent's satisfaction
Time frame: 24 hours postoperatively
Incidence of postoperative adverse events
Time frame: 24 hours postoperatively
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 9 Sep 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
Ghada MA Elfekey, MBBCH principal investigator
Faculty of Medicine, Tanta University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided sacral erector spinae plane block (sESPB) and Ultrasound-guided caudal epidural block in people with Hypospadias and Caudal Block, run by Tanta 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 12 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 9 Sep 2025. 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?
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 Ghada MA Elfekey, MBBCH (+201271600557, ghadaelfekey0@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 (0-10) during the first 24 hours after surgery (time frame: From immediately after surgery through 24 hours postoperatively: at the time of Post-Anesthesia Care Unit (PACU) arrival (0 hours), and at 30 minutes, 2 hours, 4 hours, 6 hours, 12 hours, and 24 hours after surgery.). 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 9 Sep 2025.