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

NCT ID: NCT05598255

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2025-01-01

Brief 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.

Detailed Description

All male infant patients, between ≥ 1 and < 7 years of age, undergoing circumcision will be randomized in a 1:1:1 ratio to the

1. Caudal blockade group with dexamethasone or;

2. Dorsal penile nerve block group with dexamethasone or;

3. 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.

Conditions

Analgesic Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Caudal blockade (with levobupivacaine) and dexamethasone IV

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.

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

During standard anaesthetic management: IV administration of dexamethasone (0,5mg/kg, with a maximum dose of 5mg).

Caudale Blockade with levobupivacaine

Intervention Type: PROCEDURE

Administration of levobupivacaine 0,25%0,5ml/kg through the hiatus sacralis lege artis, before incision.

Dorsal penile nerve block (with levobupivacaine) and dexamethasone IV

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.

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

During standard anaesthetic management: IV administration of dexamethasone (0,5mg/kg, with a maximum dose of 5mg).

Dorsal penile nerve block with levobupivacaine

Intervention Type: PROCEDURE

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.

Dorsal penile nerve block (with levobupivacaine)

Administration of levobupivacaine 0,5% 0,1ml/kg on each side of the midline as described in Hadzic's textbook of regional anaesthesia.

Group Type: ACTIVE_COMPARATOR

Dorsal penile nerve block with levobupivacaine

Intervention Type: PROCEDURE

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.

Interventions

Dexamethasone

During standard anaesthetic management: IV administration of dexamethasone (0,5mg/kg, with a maximum dose of 5mg).

Intervention Type: DRUG

Caudale Blockade with levobupivacaine

Administration of levobupivacaine 0,25%0,5ml/kg through the hiatus sacralis lege artis, before incision.

Intervention Type: PROCEDURE

Dorsal penile nerve block with levobupivacaine

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 7 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Algemeen Ziekenhuis Maria Middelares

OTHER

Sponsor Role: lead

Responsible Party

Joris Goossens, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joris Goossens, MD

Role: PRINCIPAL_INVESTIGATOR

Algemeen Ziekenhuis Maria Middelares

Locations

AZ Maria Middelares Gent

Ghent, Oost Vlaanderen, Belgium

Countries

Belgium

Other Identifiers

MMS.2022.006

Identifier Type: -

Identifier Source: org_study_id