Comparison of Caudal Blockade and Dorsal Penile Nerve Block With and Without the Intravenous Admi… (NCT05598255) | Clinical Trial Compass
TerminatedPhase 4
Comparison of Caudal Blockade and Dorsal Penile Nerve Block With and Without the Intravenous Administration of Dexamethasone for Analgesia After Paediatric Male Circumcision
Stopped: The study was stopped early due to low recruitment, an extended projected timeline, and the need to transfer the study to CTIS, which made continuation unfeasible.
Belgium54 participantsStarted 2022-07-01
Plain-language summary
Male infant circumcision is a frequently performed, but painful procedure. A variety of methods, both systemic and locoregional, have been developed to overcome postoperative pain after circumcision. It has been shown that local anesthetic techniques are more effective than opioids. Especially caudal block and dorsal penile nerve block provide adequate early analgesia (up to 2 hours) after circumcision.
Although the postoperative analgesic effects of CB and DPNB have been evaluated in literature before, these two techniques that are commonly used in circumcision surgery in the paediatric population, have not yet been compared when using DXM as an adjuvant in both methods. On the other hand, to our knowledge there is no evidence that indicates any other advantage than a reduced incidence in PONV when it comes to circumcision patients having a DNPB with IV DXM.
Therefore, this study aims to evaluate the analgesic effect of CB using levobupivacain with IV DXM compared to DPNB using levobupivacain with IV DXM and DPNB without IV DXM. It is questioned whether the addition of IV DXM to the DPNB might shift our standard of care towards a locoregional technique avoiding the neuraxial route, without losing the analgesic quality of the combination of a CB with IV DXM.
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:
* Male paediatric patients, between ≥ 1 and \< 7 years of age
* Patients scheduled for paediatric male circumcision (sleeve resection technique)
* Signed written informed consent form
Exclusion Criteria:
* Patients known with allergy to study medication (in this case levobupivacaine, dexamethasone, tramadol, diclofenac, paracetamol, sufentanil)
* ASA score 3 or higher (ASA physical satus classification system)
* Delayed motor development/inability to stand up
* Patients who receive medication that could possibly interact with levobupivacaine (mexiletine, ketoconazole, theophylline)
* Patients who simultaneous participate in another interventional clinical trial
* Inability of parents to understand Dutch in a sufficient way
* Soft tissue infection in the area of the procedure
* Coagulation disorder
* Spina bifida
* Autism spectrum disorder
* Ulcus ventriculi and duodeni
* Systemic fungal, bacterial and parasitic infections
* Administration of live or live-attenuated vaccins during the use of dexamethasone
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.