Analgesic EffectPhase 4NCT05598255
Comparison of Caudal Blockade and Dorsal Penile Nerve Block With and Without the Intravenous Administration of Dexamethasone for Analgesia After Paediatric Male Circumcision
A Phase 4 study testing Dexamethasone, Caudale Blockade with levobupivacaine and Dorsal penile nerve block with levobupivacaine in people with Analgesic Effect, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 7 years, men only
- Conditions the study is for
- Analgesic Effect
- What is being tested?
- Dexamethasone, Caudale Blockade with levobupivacaine and Dorsal penile nerve block with levobupivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2022to 1 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 7 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Male paediatric patients, between ≥ 1 and < 7 years of age
- Patients scheduled for paediatric male circumcision (sleeve resection technique)
- Signed written informed consent form
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Caudal blockade group with dexamethasone or;
- Dorsal penile nerve block group with dexamethasone or;
- 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.
- Conditions
- Analgesic Effect
- Being tested
- Dexamethasone, Caudale Blockade with levobupivacaine, Dorsal penile nerve block with levobupivacaine
- Keywords
- Locoregional technique, postoperative analgesic effects, caudal blockade, dorsal penile nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
During standard anaesthetic management: IV administration of dexamethasone (0,5mg/kg, with a maximum dose of 5mg).
Caudale Blockade with levobupivacaineProcedure or surgery
Administration of levobupivacaine 0,25%0,5ml/kg through the hiatus sacralis lege artis, before incision.
Dorsal penile nerve block with levobupivacaineProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Dorsal penile nerve block with levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours postoperative
Secondary outcomes (7)
Need for escape analgesia
Need for escape analgesia, in this study tramadol
Measured: 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
Measured: From PACU admission until 24 hours postoperative
Time to micturition
minutes
Measured: 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
Measured: perioperative
Length of hospital stay
Hours
Measured: From hospital admission until hospital discharge (up to 48 hours)
Time to standing up
minutes
Measured: 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
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start1 Jul 2022
- Primary completion31 Dec 2024
- Study completion1 Jan 2025
Why it stopped: The study was stopped early due to low recruitment, an extended projected timeline, and the need to transfer the study to CTIS, which made continuation unfeasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesic EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Algemeen Ziekenhuis Maria Middelares
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joris Goossens, MD, Algemeen Ziekenhuis Maria Middelares
- Investigators
- Joris Goossens, MD, Principal investigator, Algemeen Ziekenhuis Maria Middelares
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598255
- Sponsor's protocol ID
- MMS.2022.006
- Status last verified
- Jun 2025
- First submitted
- 7 Jul 2022
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05598255
- Acronym / sponsor ID
- MMS.2022.006
- Conditions
- Analgesic Effect
- Keywords
- Locoregional technique, postoperative analgesic effects, caudal blockade, dorsal penile nerve block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped early due to low recruitment, an extended projected timeline, and the need to transfer the study to CTIS, which made continuation unfeasible.
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Algemeen Ziekenhuis Maria MiddelaresUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Caudal blockade group with dexamethasone or;
- Dorsal penile nerve block group with dexamethasone or;
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Caudal blockade (with levobupivacaine) and dexamethasone IV | Active comparator | Drug: Dexamethasone, Procedure: Caudale Blockade with levobupivacaineAdministration 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. |
| Dorsal penile nerve block (with levobupivacaine) and dexamethasone IV | Active comparator | Drug: Dexamethasone, Procedure: Dorsal penile nerve block with levobupivacaineAdministration 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. |
| Dorsal penile nerve block (with levobupivacaine) | Active comparator | Procedure: Dorsal penile nerve block with levobupivacaineAdministration of levobupivacaine 0,5% 0,1ml/kg on each side of the midline as described in Hadzic's textbook of regional anaesthesia. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male paediatric patients, between ≥ 1 and < 7 years of age
- Patients scheduled for paediatric male circumcision (sleeve resection technique)
- Signed written informed consent form
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneDuring standard anaesthetic management: IV administration of dexamethasone (0,5mg/kg, with a maximum dose of 5mg). | Drug | Caudal blockade (with levobupivacaine) and dexamethasone IV, Dorsal penile nerve block (with levobupivacaine) and dexamethasone IV |
| Caudale Blockade with levobupivacaineAdministration of levobupivacaine 0,25%0,5ml/kg through the hiatus sacralis lege artis, before incision. | Procedure or surgery | Caudal blockade (with levobupivacaine) and dexamethasone IV |
| Dorsal penile nerve block with levobupivacaineAdministration of levobupivacaine 0,5% 0,1ml/kg on each side of the midline as described in Hadzic's textbook of regional anaesthesia, before incision. | Procedure or surgery | Dorsal penile nerve block (with levobupivacaine), Dorsal penile nerve block (with levobupivacaine) and dexamethasone IV |
Primary outcome
Postoperative analgesic effect
Time frame: 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
7 secondary outcomes
Need for escape analgesia
Time frame: From PACU admission until hospital discharge (up to 48 hours)
Incidence of nausea and vomiting (PONV)
Time frame: From PACU admission until 24 hours postoperative
Time to micturition
Time frame: From PACU admission until hospital discharge (up to 48 hours) (measured every 30 minutes starting from PACU admission until hospital discharge)
Total procedure time
Time frame: perioperative
Length of hospital stay
Time frame: From hospital admission until hospital discharge (up to 48 hours)
Time to standing up
Time frame: 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
Time frame: perioperative
Results and safety
The study was stopped early (reason given: The study was stopped early due to low recruitment, an extended projected timeline, and the need to transfer the study to CTIS, which made continuation unfeasible.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joris Goossens, MD principal investigator
Algemeen Ziekenhuis Maria Middelares
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone, Caudale Blockade with levobupivacaine and Dorsal penile nerve block with levobupivacaine in people with Analgesic Effect, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was stopped early due to low recruitment, an extended projected timeline, and the need to transfer the study to CTIS, which made continuation unfeasible.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative analgesic effect (time frame: 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.