Comparison of Caudal Blockade and Dorsal Penile Nerve Block With and Without the Intravenous Administration of Dexamethasone for Analgesia After Paediatric Male Circumcision: a Single Centre Randomized-controlled Trial

MMS.2022.006

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.

2022-07-01

2024-12-01

2024-12-01

Recruiting

Early phase I

75

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'patient and parents, recovery nurses and study nurse will be blinded.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 75, 'type': 'ESTIMATED'}}

2023-10-30