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

Sponsor

Algemeen Ziekenhuis Maria Middelares (Other)

Overall Status

Recruiting

CT.gov ID

NCT05598255

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Analgesic Effect	Drug: Dexamethasone Procedure: Caudale Blockade with levobupivacaine Procedure: Dorsal penile nerve block with levobupivacaine	Phase 4

Detailed Description

All male infant patients undergoing circumcision will be randomized in a 1:1 ratio to the caudal blockade group or the dorsal penile nerve block group. 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. 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. IV administration of dexamethasone 0,5mg/kg (max 5mg), 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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Masking Description:

patient and parents, recovery nurses and study nurse will be blinded.

Primary Purpose:

Supportive Care

Official Title:

Comparison of Caudal Blockade and Dorsal Penile Nerve Block in Adjunct With Dexamethasone for Analgesia After Paediatric Male Circumcision: a Single Center Randomized-controlled Trial

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

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.	Drug: Dexamethasone During standard anaesthetic management: IV administration of dexamethasone (0,5mg/kg, with a maximum dose of 5mg) in both groups (caudal blockade and dorsal penile nerve block) Procedure: Caudale Blockade with levobupivacaine Administration of levobupivacaine 0,25%0,5ml/kg through the hiatus sacralis lege artis, before incision.
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.	Drug: Dexamethasone During standard anaesthetic management: IV administration of dexamethasone (0,5mg/kg, with a maximum dose of 5mg) in both groups (caudal blockade and dorsal penile nerve block) 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.

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.

Drug: Dexamethasone

During standard anaesthetic management: IV administration of dexamethasone (0,5mg/kg, with a maximum dose of 5mg) in both groups (caudal blockade and dorsal penile nerve block)

Procedure: Caudale Blockade with levobupivacaine

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

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.

Drug: Dexamethasone

During standard anaesthetic management: IV administration of dexamethasone (0,5mg/kg, with a maximum dose of 5mg) in both groups (caudal blockade and dorsal penile nerve block)

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.

Outcome Measures

Primary Outcome Measures

Postoperative analgesic effect [24 hours postoperative]
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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 6 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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