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

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

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.

Study Overview

• Status: Terminated
• Conditions: Analgesic Effect
• Intervention / Treatment: Procedure: Caudale Blockade with levobupivacaine; Procedure: Dorsal penile nerve block with levobupivacaine; Drug: Dexamethasone

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Oost Vlaanderen
    • Gent, Oost Vlaanderen, Belgium, 9000
      • Az Maria Middelares Gent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 6 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Caudale Blockade with levobupivacaine; Administration of levobupivacaine 0,25%0,5ml/kg through the hiatus sacralis lege artis, before incision.; Drug: Dexamethasone; During standard anaesthetic management: IV administration of dexamethasone (0,5mg/kg, with a maximum dose of 5mg).
Active Comparator: 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.	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.; Drug: Dexamethasone; During standard anaesthetic management: IV administration of dexamethasone (0,5mg/kg, with a maximum dose of 5mg).
Active Comparator: 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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Algemeen Ziekenhuis Maria Middelares
• Investigators: Principal Investigator: Joris Goossens, MD, Algemeen Ziekenhuis Maria Middelares

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Locoregional technique; postoperative analgesic effects; caudal blockade; dorsal penile nerve block
• Additional Relevant MeSH Terms: Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Levobupivacaine; Dexamethasone
• Other Study ID Numbers: MMS.2022.006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No