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

NCT05598255 | Terminated Phase 4

• 1 other identifier: MMS.2022.006
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesic Effect

Keywords

Locoregional technique; postoperative analgesic effects; caudal blockade; dorsal penile nerve block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Need for escape analgesia

  From PACU admission until hospital discharge (up to 48 hours)

• Incidence of nausea and vomiting (PONV)

  From PACU admission until 24 hours postoperative

• Time to micturition

  From PACU admission until hospital discharge (up to 48 hours) (measured every 30 minutes starting from PACU admission until hospital discharge)

• Total procedure time

  perioperative

• Length of hospital stay

  From hospital admission until hospital discharge (up to 48 hours)

Study Arms (3)

Caudal blockade (with levobupivacaine) and dexamethasone IV

ACTIVE COMPARATOR

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; Procedure: Caudale Blockade with levobupivacaine

Dorsal penile nerve block (with levobupivacaine) and dexamethasone IV

ACTIVE COMPARATOR

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; Procedure: Dorsal penile nerve block with levobupivacaine

Dorsal penile nerve block (with levobupivacaine)

ACTIVE COMPARATOR

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

Interventions

Dexamethasone DRUG

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

Caudal blockade (with levobupivacaine) and dexamethasone IV; Dorsal penile nerve block (with levobupivacaine) and dexamethasone IV

Caudale Blockade with levobupivacaine PROCEDURE

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

Caudal blockade (with levobupivacaine) and dexamethasone IV

Dorsal penile nerve block with levobupivacaine 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); Dorsal penile nerve block (with levobupivacaine) and dexamethasone IV

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male paediatric patients, between ≥ 1 and \< 7 years of age
• Patients scheduled for paediatric male circumcision (sleeve resection technique)
• Signed written informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Algemeen Ziekenhuis Maria Middelares: lead

Study Sites (1)

AZ Maria Middelares Gent

Ghent, Oost Vlaanderen, 9000, Belgium

Location

MeSH Terms

Interventions

Dexamethasone; Levobupivacaine

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Joris Goossens, MD

  Algemeen Ziekenhuis Maria Middelares

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: patient and parents, recovery nurses and study nurse will be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: October 28, 2022
• Study Start: July 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: January 1, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)