Comparison of Sacral ESP Block and Dorsal Penile Nerve Block in Pediatric Hypospadias Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age1-7
SponsorMedipol University
About this trial
This randomized controlled trial aims to compare the postoperative analgesic efficacy of ultrasound-guided Sacral Erector Spinae Plane (ESP) block versus Dorsal Penile Nerve Block (DPNB) in pediatric patients aged 1-7 years undergoing hypospadias surgery. The primary outcome is the pain score assessed by the FLACC scale at the 12th postoperative hour
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pediatric male patients aged 1-7 years.
ASA (American Society of Anesthesiologists) physical status I or II.
Scheduled for elective hypospadias surgery.
Written informed consent obtained from parents/guardians
Disqualifiers
History of neurological deficit or developmental delay.
Bleeding diathesis or known coagulopathy.
History of allergy to local anesthetics.
Infection or skin lesion at the block injection site.
Trial design
Design model
Parallel
Treatments tested in this trial
Sacral ESP Block Group
Procedure/SurgeryPatients will be placed in the lateral decubitus position. Under ultrasound guidance, the plane between the multifidus muscle and the sacral lamina (erector spinae plane) will be identified at the sacral level. A total of 0.4 mL/kg of 0.25% Bupivacaine will be injected bilaterally
Dorsal Penile Nerve Block Group
Procedure/SurgeryPatients will be in the supine position. Under ultrasound guidance, the needle will be advanced under Buck's fascia at the penile base (pubic symphysis level). A total of 0.4 mL/kg of 0.25% Bupivacaine will be injected bilaterally
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Sacral ESP Block GroupExperimental treatment 1 intervention
Group B: Dorsal Penile Nerve Block GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Postoperative Pain Score (FLACC) at 12 Hours
Pain severity assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale at 30 minutes, 1, 2, 4, 6, 12 and 24 hours. The total score ranges from 0 to 10, where higher scores indicate worse pain.
Time frame
30 minutes, 1, 2, 4, 6, 12 and 24 hours post-surgerySecondary outcomes
1
Total Postoperative Analgesic Consumption
The cumulative amount of rescue analgesics (mg) consumed.
Time frame
24 hours post-surgery2
Incidence of Postoperative Complications.
Presence of motor block, urinary retention, hematoma/ecchymosis at injection site, vomiting, or pruritus.
Time frame
Up to 24 hours3
Postoperative Pain Scores (FLACC) at Other Time Points
Pain severity assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale at 30 minutes, 1, 2, 4, 6, 12 and 24 hours. The total score ranges from 0 to 10, where higher scores indicate worse pain.
Time frame
30 minutes, 1, 2, 4, 6, 12 and 24 hours post-surgerySponsors and contacts
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Medipol University
Lead sponsor
Biruni University
Collaborator
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Collaborator
Source ClinicalTrials.gov