Penile SurgeryNCT03072329
Neurostimulation in Pudendal Nerve Block
A study testing Pudendal nerve block and Bupivacaine in people with Penile Surgery, run by Hôpital d'enfants Béchir-Hamza at 1 site in Tunisia.
Trial summary
The purpose of this study is to check whether the success rate of blind pudendal nerve block in penile surgery can be optimized by the search for a motor response during neurostimulation. Read more about this study
- Who is it for?
- Ages 6 months and older, men only
- Conditions the study is for
- Penile Surgery
- What is being tested?
- Pudendal nerve block and Bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTunisia
- Study dates
- Oct 2016to 1 Mar 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 6 months and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Children scheduled for elective penile surgery (hypospadias / circumcision)
- Non-inclusion Criteria:
- Association to further peripheral nerve blocks required
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Hôpital d'Enfants Béchir Hamza
Bab Saadoun, Tunis Governorate, 1029
About this study
Official title: Neurostimulation in Pudendal Nerve Block: is That Really Necessary?
The purpose of this study is to check whether the success rate of blind pudendal nerve block in penile surgery can be optimized by the search for a motor response during neurostimulation.
- Conditions
- Penile Surgery
- Being tested
- Pudendal nerve block, Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pudendal nerve blockProcedure or surgery
BupivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Pudendal nerve block | Experimental | Bilateral pudendal nerve block with the administration of 0.1 mL/kg Bupivacaïne 0.5%, regardless of neurostimulation response. Receives: Procedure: Pudendal nerve block; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nerve block success
Nerve block success is defined by the absence of 20% increase in heart rate or systolic blood pressure baseline values
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study startOct 2016
- Primary completion20 Feb 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penile SurgeryStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital d'enfants Béchir-Hamza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Sonia ben khalifa (PhD), Hôpital d'enfants Béchir-Hamza
- Investigators
- Ben Khalifa Sonia, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072329
- Sponsor's protocol ID
- PNB-001
- Status last verified
- Mar 2017
- First submitted
- 25 Feb 2017
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurostimulation in Pudendal Nerve Block: is That Really Necessary?
- ClinicalTrials.gov ID
- NCT03072329
- Acronym / sponsor ID
- PNB-001
- Conditions
- Penile Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hôpital d'enfants Béchir-HamzaUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 20 Feb 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 7 Mar 2017 (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.
The purpose of this study is to check whether the success rate of blind pudendal nerve block in penile surgery can be optimized by the search for a motor response during neurostimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pudendal nerve block | Experimental | Procedure: Pudendal nerve block, Drug: BupivacaineBilateral pudendal nerve block with the administration of 0.1 mL/kg Bupivacaïne 0.5%, regardless of neurostimulation response. |
Who may qualify
- Ages
- 6 months and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Children scheduled for elective penile surgery (hypospadias / circumcision)
- Association to further peripheral nerve blocks required
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Pudendal nerve block | Procedure or surgery | Pudendal nerve block |
| Bupivacaine | Drug | Pudendal nerve block |
Primary outcome
Nerve block success
Time frame: 15 minutes
Nerve block success is defined by the absence of 20% increase in heart rate or systolic blood pressure baseline values
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 7 Mar 2017.
- 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.
Ben Khalifa Sonia, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pudendal nerve block and Bupivacaine in people with Penile Surgery, run by Hôpital d'enfants Béchir-Hamza at 1 site in Tunisia.
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 0 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 7 Mar 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 Tunisia. 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?
Nerve block success (time frame: 15 minutes). 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 7 Mar 2017.