Postoperative AnalgesiaNCT03258255
Analgesic Efficiency of Pudendal Nerve Block Versus Penil Block for Circumsion in Children
A study testing penil or pudendal nerve block in circumcision in people with Postoperative Analgesia, run by Istanbul University.
Trial summary
The aim of this prospective randomized study is to assess the analgesic efficacy of Pudendal block compared with penil block for pediatric patients undergoing circumsion concerning postoperative analgesic consumption within 24 hours. Read more about this study
- Who is it for?
- Ages 1 year to 12 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- penil or pudendal nerve block in circumcision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Jul 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 12 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- ASA I-II patients, aged 1-12 years old patient undergoing circumcision,
Who cannot join
- history of local anesthetics's allergy, infection at the injection side, anatomical abnormalities, coagulopaty, bleeding disease, liver disease
About this study
Official title: Comparison of Analgesic Efficiency of Pudendal Nerve Block and Penil Block for Circumsion in Children
The aim of this prospective randomized study is to assess the analgesic efficacy of Pudendal block compared with penil block for pediatric patients undergoing circumsion concerning postoperative analgesic consumption within 24 hours.
Read the detailed description
In this prospective study, patients will be randomized into 2 groups, either receiving penil Block( PNL) or nerve stimulator-guided Pudendal Nerve Block(PNB). Analgesic consumption will be assessed during the first 24 hours postoperatively. The "CHEOPS pain scale" will use to assess postoperative pain.
- Conditions
- Postoperative Analgesia
- Being tested
- penil or pudendal nerve block in circumcision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
penil or pudendal nerve block in circumcisionProcedure or surgery
regional analgesia methods during the circumsion nerve stimulator guided pudendal block performed by anesthesiologist/ penil block performed by surgeon before circumcision
| Study group | Role | What they receive |
|---|---|---|
| Pudendal block group in circumcision | Active comparator | Nerve stimulated pudendal nerve block performed under general anesthesia Receives: Procedure: penil or pudendal nerve block in circumcision |
| Penil block group in circumcision | Active comparator | Penil block performed by surgeon under general anesthesia Receives: Procedure: penil or pudendal nerve block in circumcision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain evaluatiom
CHEOPS pain scale
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study startNov 2016
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Cigdem Tutuncu, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258255
- Sponsor's protocol ID
- 242893
- Status last verified
- Nov 2017
- First submitted
- 20 Aug 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 18843636
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Efficiency of Pudendal Nerve Block and Penil Block for Circumsion in Children
- ClinicalTrials.gov ID
- NCT03258255
- Acronym / sponsor ID
- 242893
- Conditions
- Postoperative Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 23 Aug 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 aim of this prospective randomized study is to assess the analgesic efficacy of Pudendal block compared with penil block for pediatric patients undergoing circumsion concerning postoperative analgesic consumption within 24 hours.
Detailed description
In this prospective study, patients will be randomized into 2 groups, either receiving penil Block( PNL) or nerve stimulator-guided Pudendal Nerve Block(PNB). Analgesic consumption will be assessed during the first 24 hours postoperatively. The "CHEOPS pain scale" will use to assess postoperative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pudendal block group in circumcision | Active comparator | Procedure: penil or pudendal nerve block in circumcisionNerve stimulated pudendal nerve block performed under general anesthesia |
| Penil block group in circumcision | Active comparator | Procedure: penil or pudendal nerve block in circumcisionPenil block performed by surgeon under general anesthesia |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ASA I-II patients, aged 1-12 years old patient undergoing circumcision,
Key exclusion criteria (1 listed)
- history of local anesthetics's allergy, infection at the injection side, anatomical abnormalities, coagulopaty, bleeding disease, liver disease
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 |
|---|---|---|
| penil or pudendal nerve block in circumcisionregional analgesia methods during the circumsion nerve stimulator guided pudendal block performed by anesthesiologist/ penil block performed by surgeon before circumcision | Procedure or surgery | Penil block group in circumcision, Pudendal block group in circumcision |
Primary outcome
Postoperative pain evaluatiom
Time frame: 24 hour
CHEOPS pain scale
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 17 Nov 2017.
- 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing penil or pudendal nerve block in circumcision in people with Postoperative Analgesia, run by Istanbul University.
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 1 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 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Postoperative pain evaluatiom (time frame: 24 hour). 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 NCT03258255, which also lists 1 linked publication.
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 17 Nov 2017.