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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-guided sacral erector spinae plane block (sESPB) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the time of arrival to the Post-Anesthesia Care Unit (0 hours) through 24 hours after surgery. |
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Inclusion Criteria
Male only. Enrollment is limited to pediatric patients with male genitalia (sex assigned male at birth) undergoing hypospadias repair. Rationale: hypospadias is a congenital condition of the penis and occurs in males; therefore, females and other genders are not eligible."
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ghada MA Elfekey, MBBCH | Contact | +201271600557 | ghadaelfekey0@gmail.com | |
| Marwa A Eloraby, MD | Contact | +201008618309 | marwa.elfert@med.tanta.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Ghada MA Elfekey, MBBCH | Faculty of Medicine, Tanta University, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University Hospital | Recruiting | Tanta | El-Gharbia Govenorate | 31527 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author
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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.
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| Ultrasound-guided caudal epidural block | Procedure | 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. |
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| 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. | 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). | 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. | 24 hours postoperatively |
| ID | Term |
|---|---|
| D007021 | Hypospadias |
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000763 | Anesthesia, Caudal |
| ID | Term |
|---|---|
| D000767 | Anesthesia, Epidural |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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