0.8 mL/kg of 0.25% bupivacaine
Drug0.8 mL/kg of 0.25% bupivacaine
NCT Number: NCT07097844
Effective perioperative analgesia is crucial for reducing hospital stay in pediatric surgical patients. Opioid-based analgesia, although effective, may lead to respiratory depression in the postoperative period. Therefore, alternative regional anesthesia techniques such as penile block and sacral ESPB are increasingly preferred.
Sacral ESPB provides both somatic and visceral analgesia by blocking the dorsal and ventral rami of the spinal nerves. It has the potential to block the pudendal nerve and achieve bilateral effect with a single midline injection. However, comparative data between sacral ESPB and penile block in circumcision surgeries is limited.
Trial opening soon.
Get Notified2 year–7 year
All sexes
Interventional
Phase 4
Effective perioperative analgesia is crucial for reducing hospital stay in pediatric surgical patients. Opioid-based analgesia, although effective, may lead to respiratory depression in the postoperative period. Therefore, alternative regional anesthesia techniques such as penile block and sacral ESPB are increasingly preferred.
Sacral ESPB provides both somatic and visceral analgesia by blocking the dorsal and ventral rami of the spinal nerves. It has the potential to block the pudendal nerve and achieve bilateral effect with a single midline injection. However, comparative data between sacral ESPB and penile block in circumcision surgeries is limited.
In this prospective, double-blind, randomized controlled trial, 62 children aged 2 to 7 years undergoing elective circumcision at the Department of Pediatric Surgery of Diyarbakır Gazi Yaşargil Training and Research Hospital will be randomly assigned to two groups:
Group I will receive sacral ESPB using 0.8 mL/kg of 0.25% bupivacaine
Group II will receive a penile block using the same dosage and concentration.
Primary outcomes include intraoperative opioid use and postoperative rescue analgesic consumption within 24 hours. Secondary outcome includes time to discharge. Hemodynamic parameters and FLACC scores will be monitored at defined intervals.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
ASA I pediatric patients aged 2-7 years
Scheduled for elective circumcision
Informed consent obtained from parents/legal guardians
Exclusion criteria
ASA score other than I
Age <2 or >7 years
Known allergy to local anesthetics
Refusal to participate
0.8 mL/kg of 0.25% bupivacaine
Time frame: From arrival in the recovery room until 24 hours postoperatively
Postoperative pain will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) scale at 0, 15, 30, 45, 60, 90 minutes, and 2, 4, 6, 8, 10, 12, 18, and 24 hours after surgery. A FLACC score ≥4 will be treated with rescue analgesia.
Time frame: Up to 24 hours postoperatively
Measured as total intraoperative fentanyl usage and postoperative administration of paracetamol and ibuprofen.
Contact information is provided by the study sponsor or research team.
Siirt Training and Research Hospital
Other Gov
Acronym: SACRAL ESP
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