Regional AnesthesiaNCT03046290
Pudendal Block Versus Penian Block For Circumcision In Children
A study testing circumcision, Lidocaine and Ropivacaine in people with Regional Anesthesia and Postoperative Pain, run by Université Libre de Bruxelles at 1 site in Belgium.
Trial summary
The authors study the efficacy of the pudendal versus penile block for the relief of postoperative pain in children receiving ambulatory circumcision. In this prospective, double-blind, randomized, parallel-arm trial, 60 children recruited during the anesthesia consultation will be allocated a general anesthesia with… Read more about this study
- Who is it for?
- Ages 1 year to 5 years, men only
- Conditions the study is for
- Regional Anesthesia, Postoperative Pain, Circumcision
- What is being tested?
- circumcision, Lidocaine and Ropivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2017to Apr 2017
- Phase
- Interventional
- 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 5 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- circumcision in day surgery hospital
Who cannot join
- allergy to amino-amide local anesthetics
- parental consent not received
- infection at injection site
Trial locations and contacts
1 site in 1 country.
John Nicolardot contact
Belgium1 site, 1 recruiting
- Recruiting
Hopital Erasme
Bruxelles Capitale, 1070
Hopital Erasme, +3225553111, nicolardotjohn@gmail.com
turgay tuna, MD, Ph D
About this study
Official title: Pudendal Block Versus Penian Block For Circumcision In Children: A Double Blind Randomised Controlled Trial
The authors study the efficacy of the pudendal versus penile block for the relief of postoperative pain in children receiving ambulatory circumcision.
In this prospective, double-blind, randomized, parallel-arm trial, 60 children recruited during the anesthesia consultation will be allocated a general anesthesia with a pudendal block (PUD group) or a penile block (PEN group).
Each block will be made with equal parts lidocaine 1% and ropivacaine 0.75% (0.3 ml/kg).
- Conditions
- Regional Anesthesia, Postoperative Pain, Circumcision
- Being tested
- circumcision, Lidocaine, Ropivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
circumcisionProcedure or surgery
LidocaineDrug
RopivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Pudendal Block | Active comparator | The anesthesia is produced by blocking the pudendal nerves near the ischial spine of the pelvis.Local anesthetic (mixed of ropivacaine and lidocaine) is injected into the pudendal canal where the pudendal nerve is located. Receives: Procedure: circumcision; Drug: Lidocaine; Drug: Ropivacaine |
| Penian Block | Active comparator | The anesthesia is produced by blocking the dorsal penile nerves. Local anesthetic (mixed of ropivacaine and lidocaine)is injected under the pubis symphysis just below the Buck fascia where the nerve is located. Receives: Procedure: circumcision; Drug: Lidocaine; Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain score
using the FLACC (Face Leg Activity Cry Consolability) Scale
Measured: pain score at 0 hours postoperatively
Secondary outcomes (1)
Degree of satisfaction of the patient or his/her parents and the surgeon assessed by telephone interview
telephone interview
Measured: Day 5 after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study startJan 2017
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Regional AnesthesiaStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Libre de Bruxelles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JOHN NICOLARDOT, Université Libre de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046290
- Sponsor's protocol ID
- B406201630517
- Other IDs
- U1111-1191-4760
- Status last verified
- Feb 2017
- First submitted
- 10 Jan 2017
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Naja Z, Al-Tannir MA, Faysal W, Daoud N, Ziade F, El-Rajab M. A comparison of pudendal block vs dorsal penile nerve block for circumcision in children: a randomised controlled trial. Anaesthesia. 2011 Sep;66(9):802-7. doi: 10.1111/j.1365-2044.2011.06753.x. Epub 2011 Jul 25.
PubMed 21790518Faraoni D, Gilbeau A, Lingier P, Barvais L, Engelman E, Hennart D. Does ultrasound guidance improve the efficacy of dorsal penile nerve block in children? Paediatr Anaesth. 2010 Oct;20(10):931-6. doi: 10.1111/j.1460-9592.2010.03405.x.
PubMed 20849498O'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 22023417
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pudendal Block Versus Penian Block For Circumcision In Children: A Double Blind Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03046290
- Acronym / sponsor ID
- B406201630517
- Conditions
- Regional Anesthesia, Postoperative Pain, Circumcision
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Université Libre de BruxellesUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 8 Feb 2017 (estimated)
- 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.
The authors study the efficacy of the pudendal versus penile block for the relief of postoperative pain in children receiving ambulatory circumcision.
In this prospective, double-blind, randomized, parallel-arm trial, 60 children recruited during the anesthesia consultation will be allocated a general anesthesia with a pudendal block (PUD group) or a penile block (PEN group).
Each block will be made with equal parts lidocaine 1% and ropivacaine 0.75% (0.3 ml/kg).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pudendal Block | Active comparator | Procedure: circumcision, Drug: Lidocaine, Drug: RopivacaineThe anesthesia is produced by blocking the pudendal nerves near the ischial spine of the pelvis.Local anesthetic (mixed of ropivacaine and lidocaine) is injected into the pudendal canal where the pudendal nerve is located. |
| Penian Block | Active comparator | Procedure: circumcision, Drug: Lidocaine, Drug: RopivacaineThe anesthesia is produced by blocking the dorsal penile nerves. Local anesthetic (mixed of ropivacaine and lidocaine)is injected under the pubis symphysis just below the Buck fascia where the nerve is located. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- circumcision in day surgery hospital
Key exclusion criteria (3 listed)
- allergy to amino-amide local anesthetics
- parental consent not received
- infection at injection site
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 |
|---|---|---|
| circumcision | Procedure or surgery | Penian Block, Pudendal Block |
| Lidocaine | Drug | Penian Block, Pudendal Block |
| Ropivacaine | Drug | Penian Block, Pudendal Block |
Primary outcome
postoperative pain score
Time frame: pain score at 0 hours postoperatively
using the FLACC (Face Leg Activity Cry Consolability) Scale
1 secondary outcome
Degree of satisfaction of the patient or his/her parents and the surgeon assessed by telephone interview
Time frame: Day 5 after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- Background: PubMed 21790518Naja Z, Al-Tannir MA, Faysal W, Daoud N, Ziade F, El-Rajab M. A comparison of pudendal block vs dorsal penile nerve block for circumcision in children: a randomised controlled trial. Anaesthesia. 2011 Sep;66(9):802-7. doi: 10.1111/j.1365-2044.2011.06753.x. Epub 2011 Jul 25.
- Background: PubMed 20849498Faraoni D, Gilbeau A, Lingier P, Barvais L, Engelman E, Hennart D. Does ultrasound guidance improve the efficacy of dorsal penile nerve block in children? Paediatr Anaesth. 2010 Oct;20(10):931-6. doi: 10.1111/j.1460-9592.2010.03405.x.
- 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.
- 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.
John Nicolardot contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing circumcision, Lidocaine and Ropivacaine in people with Regional Anesthesia and Postoperative Pain, run by Université Libre de Bruxelles 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Feb 2017. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Nicolardot, MD (+3225555288, nicolardotjohn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain score (time frame: pain score at 0 hours postoperatively). 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 NCT03046290, which also lists 3 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 Feb 2017.