Comparison of Caudal Blockade and Dorsal Penile Nerve Block With and Without the Intravenous Administration of Dexamethasone for Analgesia After Paediatric Male Circumcision

Study Overview
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Brief Summary
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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.

Detailed Description
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All male infant patients, between ≥ 1 and < 7 years of age, undergoing circumcision will be randomized in a 1:1:1 ratio to the Caudal blockade group with dexamethasone or; Dorsal penile nerve block group with dexamethasone or; Dorsal penile nerve block group withouth dexamethasone. After induction of anaesthesia the allocated locoregional anaesthesia technique will be performed. For the caudal blockade group levobupivacaine 0,25% 0,5ml/kg will be administered through the hiatus sacralis lege artis. After performing the caudal blocakde, IV administration of dexamethasone 0.5 mg/kg (max. 5 mg). For the dorsal penile nerve block levobupivacaine 0,5% 0,1ml/kg will be administered on each side of the midline as described in Hadzic's textbook of regional anaesthesia. After performing of the dorsal penile nerve block, IV administration of dexamethasone 0.5 mg/kg (max. 5 mg) in patients in the dorsal penile nerve block group with dexamethasone . IV administration of diclofenac 1mg/kg and paracetamol 15mg/kg for both groups. If heart rate raises with >20% from baseline within 2 minutes after incision, administration of sufentanyl (0,1µg/kg IV) is necessary. Pain scores are evaluated after awakening at PACU, measured by the FLACC scale, at following timepoints: 30 minutes, 1 hour, 2 hours, 6 hours, 12 hours and 24 hours postoperative. During recovery stay till hospital discharge pain scores will be registered by the study nurse. Registration of pain scores after hospital discharge (till 24 hours postoperative) will be performed by (one of) the parents of the patient, who will be educated how to use the FLACC scale by the study nurse. A follow up phone call will be performed by the study nurse to collect the remaining pain scores starting from hospital discharge. Pain medication exists of standard administration of paracetamol PO 15mg/kg every 6 hours (starting 6 hours after the intraoperative administered dose) and ibuprofen PO 10mg/kg every 8 hours (starting 8 hours after the intraoperative administered diclofenac). When FLACC score remains above 3, rescue pain medication will be administered during hospital stay. Rescue pain medication consists of tramadol intravenously (PACU) or oral drops (ward) 1mg/kg and can be repeated at maximum every 6 hours.

Official Title
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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

Conditions
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Analgesic Effect

Intervention / Treatment
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* Drug: Dexamethasone
* Procedure: Caudale Blockade with levobupivacaine
* Procedure: Dorsal penile nerve block with levobupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 7 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Caudal blockade (with levobupivacaine) and dexamethasone IV<br>Administration of levobupivacaine 0,25% 0,5 ml/kg through the hiatus sacralis lege artis. IV administration of dexamethasone 0,5mg/kg (max. 5mg) during standard anaesthetic management. | Drug: Dexamethasone<br>* During standard anaesthetic management: IV administration of dexamethasone (0,5mg/kg, with a maximum dose of 5mg).<br>Procedure: Caudale Blockade with levobupivacaine<br>* Administration of levobupivacaine 0,25%0,5ml/kg through the hiatus sacralis lege artis, before incision.<br>|
| Active Comparator: Dorsal penile nerve block (with levobupivacaine) and dexamethasone IV<br>Administration of levobupivacaine 0,5% 0,1ml/kg on each side of the midline as described in Hadzic's textbook of regional anaesthesia. IV administration of dexamethasone 0,5mg/kg (max. 5mg) during standard anaesthetic management. | Drug: Dexamethasone<br>* During standard anaesthetic management: IV administration of dexamethasone (0,5mg/kg, with a maximum dose of 5mg).<br>Procedure: Dorsal penile nerve block with levobupivacaine<br>* Administration of levobupivacaine 0,5% 0,1ml/kg on each side of the midline as described in Hadzic's textbook of regional anaesthesia, before incision.<br>|
| Active Comparator: Dorsal penile nerve block (with levobupivacaine)<br>Administration of levobupivacaine 0,5% 0,1ml/kg on each side of the midline as described in Hadzic's textbook of regional anaesthesia. | Procedure: Dorsal penile nerve block with levobupivacaine<br>* Administration of levobupivacaine 0,5% 0,1ml/kg on each side of the midline as described in Hadzic's textbook of regional anaesthesia, before incision.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative analgesic effect | Analgesic effect of a caudal blockade after circumcision in paediatric patients compared to dorsal penile nerve block after circumcision in paediatric patients measured by the FLACC scale (= Face, Legs, Activity, Cry, Consolability) at 30 minutes, 1, 2, 6, 12 and 24 hours postoperative | 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for escape analgesia | Need for escape analgesia, in this study tramadol | From PACU admission until hospital discharge (up to 48 hours) | 
| Incidence of nausea and vomiting (PONV) | Incidence of nausea and vomiting at 30 minutes, 1, 2, 6, 12 and 24 hours postoperative | From PACU admission until 24 hours postoperative | 
| Time to micturition | minutes | From PACU admission until hospital discharge (up to 48 hours) (measured every 30 minutes starting from PACU admission until hospital discharge) | 
| Total procedure time | minutes | perioperative | 
| Length of hospital stay | Hours | From hospital admission until hospital discharge (up to 48 hours) | 
| Time to standing up | minutes | From PACU admission until hospital discharge (up to 48 hours) (measured every 30 minutes starting from PACU admission until hospital discharge) | 
| Need for supplemental sufentanil intraoperatively | If heart rate raises with >20% from baseline within 2 minutes after incision, administration of sufentanil (0.1 µg/kg IV) is necessary | perioperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Locoregional technique, postoperative analgesic effects, caudal blockade, dorsal penile nerve block