Child, OnlyNCT04475458
Pediatric Ultrasound-guided Dorsal Penile Nerve Block Plus Sedation in Spontaneous Breathing
An observational study of Child, Only, run by Azienda Sanitaria-Universitaria Integrata di Udine at 1 site in Italy.
Trial summary
One of the most frequent surgical procedures in the pediatric population is circumcision, following which postoperative pain could be stressful. Usually, the most common approach is combining regional anesthesia techniques such as landmark dorsal penile nerve block (DPNB) with general anesthesia (GA). Read more about this study
- Who is it for?
- Ages 6 months to 17 years, men only
- Conditions the study is for
- Child, Only
- What is being tested?
- Ultrasound-guided dorsal penile nerve block
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2016to 1 Oct 2021
- Phase
- Observational
- 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 6 months to 17 years
- Men only
- No healthy volunteers
- Child
Study population: Patients' anthropometric data were collected. Data related to the anesthetic technique, pharmacological therapy, vital parameters were registered as well as the time to discharge from the operatory room to the post-anesthesia care unit. Opioid consumption and nonsteroidal anti-inflammatory drugs during and after surgery were noted. Pain and complications immediately after surgery, at 4 and 72 hours after surgery were registered.
Who may be able to join
- candidates to circumcision
- age between 6 months and 17 years
- American Society of Anesthesiologists (ASA) physical status < 3
- written consent of the parents
Who cannot join
- allergies to local anesthetics
- younger than 6 months and older than 17 years
- ASA physical status =/> 3
- no written consent of the parents
Trial locations and contacts
1 site in 1 country.
Italy1 site
Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD
Udine, 33100
About this study
Official title: Pediatric Ultrasound-guided Dorsal Penile Nerve Block Plus Sedation in Spontaneous Breathing: An Observational Study
One of the most frequent surgical procedures in the pediatric population is circumcision, following which postoperative pain could be stressful. Usually, the most common approach is combining regional anesthesia techniques such as landmark dorsal penile nerve block (DPNB) with general anesthesia (GA). The hypothesis of this study investigates ultrasound-guided DPNB plus sedation in spontaneous breathing.
- Conditions
- Child, Only
- Being tested
- Ultrasound-guided dorsal penile nerve block
- Keywords
- dorsal nerve penis block, sedation, spontaneous breathing, circumcision, pediatric surgery, ultrasound guided
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided dorsal penile nerve blockProcedure or surgery
This block is performed by the anesthesiologist, after sedation. With an in-plane approach, the tissues around the dorsal penis nerves are visualized. The needle has to pass through Buck's fascia and there the local anesthetic is released.
| Study group | Role | What they receive |
|---|---|---|
| LANDMARK | The children who underwent circumcision received general anesthesia plus dorsal penis nerve block performed by the surgeon with a landmark technique. | |
| ULTRASOUND | The children who underwent circumcision received sedation (in spontaneous breathing) plus ultrasound-guided dorsal penis nerve block. Receives: Procedure: Ultrasound-guided dorsal penile nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to discharge
The time to discharge from the operating room to the post-anesthesia care unit is measured and compared between the two groups.
Measured: 1 hour after end of surgery
Secondary outcomes (4)
Number of patients needed ventilation
Patients who received general anesthesia where all ventilated mechanically. In the ultrasound group, patients maintained spontaneous breathing and were noted the ones who needed ventilation.
Measured: 1 hour after beginning of surgery
Opioid sparing
The dosage of opioids were measured and compared between the two groups.
Measured: 1 hour after beginning of surgery
Postoperative pain
Pain levels were compared between the two groups with the Faces, Legs, Activity, Cry and Consolability (FLACC) scale for children < 3 years (a score between 0 and 3 corresponds to a slight pain, in the range 4-7 to moderate pain and score> 7 to a severe pain), faces pain scale for children between 3 e 8 years (the scale shows a series of faces ranging from a happy face or no hurt at score 0, to a crying face at score 10, which represents "hurts like the worst pain imaginable", the patient chooses the face that best describes their level of pain) and the numerical rate scale (NRS) for children > 8 years-old (patients are asked to circle the number between 0 and 10 that fits best to their pain intensity, zero represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'). Analgesics and nonsteroidal anti-inflammatory drugs were registered in the two groups.
Measured: Immediately after surgery, 4 and 72 hours after surgery
Complications
Postoperative complications were analyzed and compared between the two groups.
Measured: Immediately after surgery, 4 and 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start1 Jan 2016
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Child, OnlyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria-Universitaria Integrata di Udine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Vetrugno, Azienda Sanitaria-Universitaria Integrata di Udine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475458
- Sponsor's protocol ID
- Ultrasound guided DPNB
- Status last verified
- Nov 2022
- First submitted
- 10 Jul 2020
- Last updated
- 8 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cyna AM, Middleton P. Caudal epidural block versus other methods of postoperative pain relief for circumcision in boys. Cochrane Database Syst Rev. 2008 Oct 8;2008(4):CD003005. doi: 10.1002/14651858.CD003005.pub2.
PubMed 18843636Suleman MI, Akbar Ali AN, Kanarek V, Li M, Patel A. Ultrasound Guided In-Plane Penile Nerve Block for Circumcision: A New, Modified Technique Suggests Lower Anesthetic Volume and Narcotic Use. Middle East J Anaesthesiol. 2016 Oct;23(6):647-53.
PubMed 29939703Sandeman DJ, Dilley AV. Ultrasound guided dorsal penile nerve block in children. Anaesth Intensive Care. 2007 Apr;35(2):266-9. doi: 10.1177/0310057X0703500217.
PubMed 17444318O'Sullivan MJ, Mislovic B, Alexander E. Dorsal penile nerve block for male pediatric circumcision--randomized comparison of ultrasound-guided vs anatomical landmark technique. Paediatr Anaesth. 2011 Dec;21(12):1214-8. doi: 10.1111/j.1460-9592.2011.03722.x.
PubMed 22023417Dottore B, Meroi F, Tomasino S, Orso D, Comuzzi M, Vernaccini N, Vetrugno L, Intini S, Bove T. Pediatric ultrasound-guided dorsal penile nerve block and sedation in spontaneous breathing: a prospective observational study. Front Med (Lausanne). 2023 Dec 4;10:1268594. doi: 10.3389/fmed.2023.1268594. eCollection 2023.
PubMed 38116040
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Ultrasound-guided Dorsal Penile Nerve Block Plus Sedation in Spontaneous Breathing: An Observational Study
- ClinicalTrials.gov ID
- NCT04475458
- Acronym / sponsor ID
- Ultrasound guided DPNB
- Conditions
- Child, Only
- Keywords
- dorsal nerve penis block, sedation, spontaneous breathing, circumcision, pediatric surgery, ultrasound guided
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Azienda Sanitaria-Universitaria Integrata di UdineUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 17 Jul 2020 (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.
One of the most frequent surgical procedures in the pediatric population is circumcision, following which postoperative pain could be stressful. Usually, the most common approach is combining regional anesthesia techniques such as landmark dorsal penile nerve block (DPNB) with general anesthesia (GA). The hypothesis of this study investigates ultrasound-guided DPNB plus sedation in spontaneous breathing.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LANDMARK | – | –The children who underwent circumcision received general anesthesia plus dorsal penis nerve block performed by the surgeon with a landmark technique. |
| ULTRASOUND | – | Procedure: Ultrasound-guided dorsal penile nerve blockThe children who underwent circumcision received sedation (in spontaneous breathing) plus ultrasound-guided dorsal penis nerve block. |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients' anthropometric data were collected. Data related to the anesthetic technique, pharmacological therapy, vital parameters were registered as well as the time to discharge from the operatory room to the post-anesthesia care unit. Opioid consumption and nonsteroidal anti-inflammatory drugs during and after surgery were noted. Pain and complications immediately after surgery, at 4 and 72 hours after surgery were registered.
Key inclusion criteria (4 listed)
- candidates to circumcision
- age between 6 months and 17 years
- American Society of Anesthesiologists (ASA) physical status < 3
- written consent of the parents
Key exclusion criteria (4 listed)
- allergies to local anesthetics
- younger than 6 months and older than 17 years
- ASA physical status =/> 3
- no written consent of the parents
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 |
|---|---|---|
| Ultrasound-guided dorsal penile nerve blockThis block is performed by the anesthesiologist, after sedation. With an in-plane approach, the tissues around the dorsal penis nerves are visualized. The needle has to pass through Buck's fascia and there the local anesthetic is released. | Procedure or surgery | ULTRASOUND |
Primary outcome
Time to discharge
Time frame: 1 hour after end of surgery
The time to discharge from the operating room to the post-anesthesia care unit is measured and compared between the two groups.
4 secondary outcomes
Number of patients needed ventilation
Time frame: 1 hour after beginning of surgery
Opioid sparing
Time frame: 1 hour after beginning of surgery
Postoperative pain
Time frame: Immediately after surgery, 4 and 72 hours after surgery
Complications
Time frame: Immediately after surgery, 4 and 72 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Background: PubMed 18843636Cyna AM, Middleton P. Caudal epidural block versus other methods of postoperative pain relief for circumcision in boys. Cochrane Database Syst Rev. 2008 Oct 8;2008(4):CD003005. doi: 10.1002/14651858.CD003005.pub2.
- Background: PubMed 29939703Suleman MI, Akbar Ali AN, Kanarek V, Li M, Patel A. Ultrasound Guided In-Plane Penile Nerve Block for Circumcision: A New, Modified Technique Suggests Lower Anesthetic Volume and Narcotic Use. Middle East J Anaesthesiol. 2016 Oct;23(6):647-53.
- Background: PubMed 17444318Sandeman DJ, Dilley AV. Ultrasound guided dorsal penile nerve block in children. Anaesth Intensive Care. 2007 Apr;35(2):266-9. doi: 10.1177/0310057X0703500217.
- Background: PubMed 22023417O'Sullivan MJ, Mislovic B, Alexander E. Dorsal penile nerve block for male pediatric circumcision--randomized comparison of ultrasound-guided vs anatomical landmark technique. Paediatr Anaesth. 2011 Dec;21(12):1214-8. doi: 10.1111/j.1460-9592.2011.03722.x.
- Derived from this study: PubMed 38116040Dottore B, Meroi F, Tomasino S, Orso D, Comuzzi M, Vernaccini N, Vetrugno L, Intini S, Bove T. Pediatric ultrasound-guided dorsal penile nerve block and sedation in spontaneous breathing: a prospective observational study. Front Med (Lausanne). 2023 Dec 4;10:1268594. doi: 10.3389/fmed.2023.1268594. eCollection 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child, Only, run by Azienda Sanitaria-Universitaria Integrata di Udine at 1 site in Italy.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 8 Nov 2022. 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 Italy. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to discharge (time frame: 1 hour after end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04475458, which also lists 5 linked publications.
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 8 Nov 2022.