Comparison of Caudal Block and Retrolaminar Block for Circumcision (NCT06584292) | Clinical Trial Compass
WithdrawnNot Applicable
Comparison of Caudal Block and Retrolaminar Block for Circumcision
Stopped: we couldn't find enough patient.
Turkey (Türkiye)0Started 2022-09-27
Plain-language summary
Primary Outcome:
Analgesic Efficiency: The primary outcome is the comparison of the analgesic efficacy of the retrolaminar block (RL) versus caudal block (CB) based on postoperative pain scores measured by the FLACC score. This outcome aims to evaluate how effectively each block controls postoperative pain.
Secondary Outcomes:
Analgesic Requirements:
The amount of analgesic required within the first 24 hours postoperatively. The time to the first analgesic requirement. These will be recorded during postoperative follow-up visits at 30 minutes, 1, 2, 4, 6, 12, and 24 hours by an anesthesiologist who is blinded to the study groups.
Postoperative Complications:
Urinary Retention: Defined as a distended palpable bladder associated with pain.
Motor Block: The presence of lower extremity motor block will be evaluated using the modified Bromage scale (0: No motor block; 1: Able to move the legs; 2: Unable to move the legs).
Ecchymosis and Hematoma: The presence of ecchymosis (discoloration of the skin due to blood infiltration in the subcutaneous tissues) and hematoma (abnormal swelling or hardening caused by the accumulation of blood) at the injection site will be assessed.
Who can participate
Age range
1 Year – 7 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pediatric patients aged 1 to 7 years.
* Classified as American Society of Anesthesiologists (ASA) physical status I-II.
* Scheduled for elective, unilateral lower abdominal surgery (e.g., orchiopexy or hydrocelectomy) combined with circumcision.
* Patients whose parents or legal guardians provided written informed consent.
Exclusion Criteria:
* Patients younger than 1 year or older than 7 years.
* Presence of neurological deficits.
* Bleeding disorders.
* History of allergy to local anesthetic drugs.
* Presence of redness or infection at the injection site on physical examination.
* Any congenital spinal anomalies.
* Intellectual disabilities or psychiatric disorders.
* Liver and/or kidney disease.
* Patients or their guardians who declined to participate in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Analgesic Efficiency
Timeframe: 1 day
Trial details
NCT IDNCT06584292
SponsorKanuni Sultan Suleyman Training and Research Hospital