Comparing two pain management techniques for children undergoing undescended testis surgery
Comparison of the Effects of Caudal Block and Retrolaminar Block on Analgesic Consumption in Postoperative Pain Management for Pediatric Undescended Testis Surgeries
NA · Kanuni Sultan Suleyman Training and Research Hospital · NCT06725862
This study is testing which of two pain management techniques works better for young children having surgery for undescended testis to help them feel less pain after the operation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 1 Year to 7 Years |
| Sex | Male |
| Sponsor | Kanuni Sultan Suleyman Training and Research Hospital (other) |
| Locations | 2 sites (Istanbul and 1 other locations) |
| Trial ID | NCT06725862 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of two regional anesthesia techniques, Caudal Block (CB) and Retrolaminar Block (RLB), in managing postoperative pain in pediatric patients aged 1-7 years undergoing surgery for undescended testis. The study is designed as a double-blind, randomized controlled trial, where participants will be assigned to one of the two techniques, and pain levels will be assessed using the FLACC pain scale by a blinded nurse. The goal is to determine which method provides better pain relief and reduces the need for systemic analgesics, thereby improving recovery outcomes for children. Both techniques involve the administration of bupivacaine under ultrasound guidance to ensure precise delivery of the anesthetic.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients aged 1-7 years with ASA physical status I or II scheduled for unilateral undescended testis surgery.
Not a fit: Patients with contraindications such as spinal anomalies, allergies to local anesthetics, or other significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for pediatric patients, enhancing recovery and reducing complications after surgery.
How similar studies have performed: While the caudal block is a well-established technique, the retrolaminar block is relatively new, and studies comparing these two methods in pediatric patients are limited, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Pediatric patients aged 1-7 years. ASA (American Society of Anesthesiologists) physical status I or II. Scheduled for unilateral undescended testis surgery. Parental/guardian consent provided for study participation. Exclusion Criteria: Age under 1 year or over 7 years. Neurological deficits. Coagulopathy or bleeding disorders. History of allergy to local anesthetics. Signs of redness, infection, or other abnormalities at the injection site. Congenital spinal anomalies. Intellectual disability or psychiatric disorders. Hepatic or renal impairment. Refusal to participate in the study by parents or guardians.
Where this trial is running
Istanbul and 1 other locations
- Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital — Istanbul, Turkey (Türkiye) (RECRUITING)
- Zincirlikuyu Medicana Hospital — Istanbul, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: Engin ihsan Turan — Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
- Study coordinator: Engin ihsan Turan
- Email: enginihsan@hotmail.com
- Phone: 05382431114
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Post Operative Pain