Clinical trial NCT05598255: Comparison of Caudal Blockade and Dorsal Penile Nerve Block With and Without the Intravenous Administration of Dexamethasone for Analgesia After Paediatric Male Circumcision
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Analgesic Effect
Keywords: Locoregional technique
postoperative analgesic effects
caudal blockade
dorsal penile nerve block
Lead sponsor: Algemeen Ziekenhuis Maria Middelares
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 54
Sex: MALE
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Postoperative analgesic effect
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Need for escape analgesia
timeFrame: From PACU admission until hospital discharge (up to 48 hours)
measure: Incidence of nausea and vomiting (PONV)
timeFrame: From PACU admission until 24 hours postoperative
measure: Time to micturition
timeFrame: From PACU admission until hospital discharge (up to 48 hours) (measured every 30 minutes starting from PACU admission until hospital discharge)
measure: Total procedure time
timeFrame: perioperative
measure: Length of hospital stay
timeFrame: From hospital admission until hospital discharge (up to 48 hours)
measure: Time to standing up
timeFrame: From PACU admission until hospital discharge (up to 48 hours) (measured every 30 minutes starting from PACU admission until hospital discharge)
measure: Need for supplemental sufentanil intraoperatively
timeFrame: perioperative
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: AZ Maria Middelares Gent
state: Oost Vlaanderen
Study officials:
affiliation: Algemeen Ziekenhuis Maria Middelares
name: Joris Goossens, MD
role: PRINCIPAL_INVESTIGATOR
References: