A Comparison of the Efficacy of Sacral Erector Spinae Plane Block and Penile Block in Circumcision Surgery
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 0.8 mL/kg of 0.25% bupivacaine.
- Who it may be relevant to
- Registry conditions: Elective Circumcision Surgery. Basic parameters: 2 years — 7 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Drug 0.8 mL/kg of 0.25% bupivacaine
0.8 mL/kg of 0.25% bupivacaine
Primary outcome measures
- FLACC Pain Score [Time frame: From arrival in the recovery room until 24 hours postoperatively]
Secondary outcome measures (1)
- Total Perioperative Opioid and Rescue Analgesic Consumption [Time frame: Up to 24 hours postoperatively]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07097844 · SAĞLIK BİLİMLERİ ÜNİVERSİTESİ