Comparison of Caudal Blockade and Dorsal Penile Nerve Block in Adjunct With Dexamethasone in Circumcision

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: Male

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 caudal blockade and dorsal penile nerve block, two techniques that are commonly used in circumcision surgery in the paediatric population, have been compared in literature, no study evaluated the postoperative analgesic effects of the two techniques when using dexamethasone as adjuvant in both methods.

Therefore, this study aims to evaluate the analgesic effect (measured by FLACC) of caudal blockade using levobupivacaine with IV dexamethasone versus dorsal penile nerve block using levobupivacaine with IV dexamethasone. It is questioned whether the addition of IV dexamethasone to the dorsal penile nerve block might shift our standard of care towards one of the mentioned techniques.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Algemeen Ziekenhuis Maria Middelares
• Treatments: Dexamethasone; Levobupivacaine

Criteria

Inclusion Criteria:

• Male paediatric patients, between 1 and 6 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, sufentanyl)

• 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