Actively Recruiting
Comparison of Caudal Block and Retrolaminar Block Effects on Postoperative Pain and Analgesic Use in Pediatric Undescended Testis Surgery
Led by Kanuni Sultan Suleyman Training and Research Hospital · Updated on 2025-02-18
60
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of two regional anesthesia techniques, Caudal Block (CB) and Retrolaminar Block (RLB), for managing postoperative pain in children undergoing surgery for undescended testis. This study focuses on pediatric patients aged 1 to 7 years who are classified as ASA I-II and aims to compare pain scores, time to first analgesic use, and postoperative complications. The research is a double-blind, randomized controlled trial conducted at two hospitals. Participants will be randomly assigned to receive either the Caudal Block or the Retrolaminar Block after general anesthesia induction. The Caudal Block involves injecting 0.125% bupivacaine into the sacral canal, while the Retrolaminar Block uses 0.25% bupivacaine injected into the retrolaminar space at the L4 vertebral level, both performed under ultrasound guidance by an experienced operator. General anesthesia includes premedication with midazolam, induction with propofol and fentanyl, and maintenance with sevoflurane. During the 24-hour postoperative period, pain will be assessed at multiple timepoints using the FLACC pain scale by a blinded nurse. Patients with mild to moderate pain will receive intravenous paracetamol, while those with higher pain scores will be given intravenous tramadol. Researchers will monitor analgesic consumption, pain scores, and any complications. The study includes detailed follow-up assessments to provide valuable data on these two pain management techniques in pediatric surgery.
CONDITIONS
Brief Title
Caudal Block vs Retrolaminar Block on Analgesic Consumption in Undescended Testis Surgeries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric patients aged 1-7 years
- ASA physical status I or II
- Scheduled for unilateral undescended testis surgery
- Parental or guardian consent provided
You will not qualify if you...
- Age under 1 year or over 7 years
- Neurological deficits
- Coagulopathy or bleeding disorders
- Allergy to local anesthetics
- Redness, infection, or abnormalities at injection site
- Congenital spinal anomalies
- Intellectual disability or psychiatric disorders
- Liver or kidney disease
- Refusal by parents or guardians to participate in the study
- Female gender (implied by study population male only in screening question and criteria description, but not explicitly stated in exclusion; included here for clarity of participant gender restriction as per source data)
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day
Participants undergo general anesthesia followed by either a retrolaminar block or a caudal block for pain management during undescended testis surgery.
1 visit (in-person, day of surgery)
Duration - Up to 24 hours postoperatively
Participants are monitored for postoperative pain and analgesic use for 24 hours after surgery.
Multiple pain assessments at 30 minutes, 1, 2, 4, 6, 12, and 24 hours post-surgery
Trial Site Locations
Total: 2 locations
1
Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
Istanbul, Turkey (Türkiye), 34303
Actively Recruiting
2
Zincirlikuyu Medicana Hospital
Istanbul, Turkey (Türkiye)
Actively Recruiting
Research Team
E
Engin ihsan Turan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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