Caudal Block, Erector Spinae Plane Block, Hypospadias, Pain, Postoperative
Conditions
Keywords
hypospadias, nerve block, erector spinae plane block, caudal block, pain, ultra-sound
Brief 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. 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.
Interventions
PROCEDUREUltrasound-guided sacral erector spinae plane block (sESPB)
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.
PROCEDUREUltrasound-guided caudal epidural 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.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
MALE
Age
1 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FLACC pain score (0-10) during the first 24 hours after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first rescue analgesia requirement postoperatively | From the time of arrival to the Post-Anesthesia Care Unit (0 hours) until the first rescue dose, within 24 hours after surgery | If FLACC pain score ≥ 4 I.V pethidine 0.5 mg/kg will be given as rescue analgesia. |
| Total opioid consumption (pethidine), 0-24 h (mg/kg) | From the time of arrival to the Post-Anesthesia Care Unit (0 hours) through 24 hours after surgery. | 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. |
| Parent's satisfaction | 24 hours postoperatively | Parent's Satisfaction Level were recorded on a numerical scale from 1 to 3 (not satisfied - neutral - satisfied). |
| Incidence of postoperative adverse events | 24 hours postoperatively | 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. |
Countries
Egypt
Contacts
Primary ContactGhada MA Elfekey, MBBCH
Backup ContactMarwa A Eloraby, MD
Outcome results
None listed