PainPhase 4NCT02390388
Pudendal Block Versus Caudal Block for Hypospadias
A Phase 4 study testing pudendal nerve block and caudal block in people with Pain, run by Istanbul University.
Trial summary
The aim of this prospective randomized study is to assess the analgesic efficacy and duration of Pudendal block compared with Caudal block for pediatric patients undergoing hypospadias surgery concerning intraoperative analgesic and also postoperative total analgesic consumption within 24 hours. Read more about this study
- Who is it for?
- Ages 1 year to 10 years, men only
- Conditions the study is for
- Pain
- What is being tested?
- pudendal nerve block and caudal block
- 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 2014to May 2015
- 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 10 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- ASA physical status I-II
- aged 1 to 10 years scheduled undergoing hypospadias surgery
Who cannot join
- history of allergic reactions to local anesthetics
- rash or infection at the injection site
- anatomical abnormality
- bleeding diatheses, coagulopathy, liver diseases
About this study
Official title: A Comparison of Effectiveness of Pudendal Nerve Block vs Caudal Block for Hypospadias Surgery in Children
The aim of this prospective randomized study is to assess the analgesic efficacy and duration of Pudendal block compared with Caudal block for pediatric patients undergoing hypospadias surgery concerning intraoperative analgesic and also postoperative total analgesic consumption within 24 hours.
Read the detailed description
In this prospective study, patients will be randomized into 2 groups, either receiving Caudal Block(CB) 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
- Pain
- Being tested
- pudendal nerve block, caudal block
- Keywords
- pudendal block, Hypospadias, caudal block, child, analgesia
- Medical subject headings
- Pain, Hypospadias, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pudendal nerve blockProcedure or surgery
nerve stimulator-guided Pudendal block
caudal blockProcedure or surgery
caudal block
| Study group | Role | What they receive |
|---|---|---|
| pudendal block group | Active comparator | nerve stimulated pudendal nerve block performed under general anesthesia Receives: Procedure: pudendal nerve block |
| Caudal block group | Active comparator | caudal block performed under general anesthesia Receives: Procedure: caudal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain intensity measure
pain scores are recorded (postoperative within 24 hours) the investigators use CHEOPS pain scale for evaluation pain intensity. When pain score is 7 or higher than 7, pain treatment is evaluated as inadequate.
Measured: 24 hours
Secondary outcomes (5)
time to to first use of analgesic
Measured: 24 hours
parental satisfaction
Parent satisfaction was scored as:
- definitely unsatisfied;
- satisfied;
- definitely satisfied.
Measured: 24 hours
the incidence of side effects
Measured: 24 hours
intraoperative analgesic requirement
intraoperative remifentanil infusion requirement ( If heart rate and/or blood pressure increase 20% than first measure, we will start remifentanil infusion)
Measured: intraoperative
postoperative total analgesic requirements
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startNov 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Ayse Cigdem Tutuncu, Senol Emre, Fatis Altindas, Kaya, Guner, M.D.
- Responsible party
- Principal investigator, pinar kendigelen, Istanbul University
- Investigators
- Guner Kaya, Prof., Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390388
- Sponsor's protocol ID
- 242890
- Status last verified
- Aug 2015
- First submitted
- 26 Jan 2015
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Naja ZM, Ziade FM, Kamel R, El-Kayali S, Daoud N, El-Rajab MA. The effectiveness of pudendal nerve block versus caudal block anesthesia for hypospadias in children. Anesth Analg. 2013 Dec;117(6):1401-7. doi: 10.1213/ANE.0b013e3182a8ee52.
PubMed 24257391Kendigelen P, Tutuncu AC, Emre S, Altindas F, Kaya G. Pudendal Versus Caudal Block in Children Undergoing Hypospadias Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):610-5. doi: 10.1097/AAP.0000000000000447.
PubMed 27501015
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Effectiveness of Pudendal Nerve Block vs Caudal Block for Hypospadias Surgery in Children
- ClinicalTrials.gov ID
- NCT02390388
- Acronym / sponsor ID
- 242890
- Conditions
- Pain
- Keywords
- pudendal block, Hypospadias, caudal block, child, analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Ayse Cigdem Tutuncu, Senol Emre, Fatis Altindas, Kaya, Guner, M.D.
- Study start
- Nov 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 17 Mar 2015 (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 aim of this prospective randomized study is to assess the analgesic efficacy and duration of Pudendal block compared with Caudal block for pediatric patients undergoing hypospadias surgery concerning intraoperative analgesic and also postoperative total analgesic consumption within 24 hours.
Detailed description
In this prospective study, patients will be randomized into 2 groups, either receiving Caudal Block(CB) 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
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pudendal block group | Active comparator | Procedure: pudendal nerve blocknerve stimulated pudendal nerve block performed under general anesthesia |
| Caudal block group | Active comparator | Procedure: caudal blockcaudal block performed under general anesthesia |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ASA physical status I-II
- aged 1 to 10 years scheduled undergoing hypospadias surgery
Key exclusion criteria (4 listed)
- history of allergic reactions to local anesthetics
- rash or infection at the injection site
- anatomical abnormality
- bleeding diatheses, coagulopathy, liver diseases
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 blocknerve stimulator-guided Pudendal block | Procedure or surgery | pudendal block group |
| caudal blockcaudal block | Procedure or surgery | Caudal block group |
Primary outcome
postoperative pain intensity measure
Time frame: 24 hours
pain scores are recorded (postoperative within 24 hours) the investigators use CHEOPS pain scale for evaluation pain intensity. When pain score is 7 or higher than 7, pain treatment is evaluated as inadequate.
5 secondary outcomes
time to to first use of analgesic
Time frame: 24 hours
parental satisfaction
Time frame: 24 hours
the incidence of side effects
Time frame: 24 hours
intraoperative analgesic requirement
Time frame: intraoperative
postoperative total analgesic requirements
Time frame: 24 hours
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 26 Aug 2015.
- Background: PubMed 24257391Naja ZM, Ziade FM, Kamel R, El-Kayali S, Daoud N, El-Rajab MA. The effectiveness of pudendal nerve block versus caudal block anesthesia for hypospadias in children. Anesth Analg. 2013 Dec;117(6):1401-7. doi: 10.1213/ANE.0b013e3182a8ee52.
- Derived from this study: PubMed 27501015Kendigelen P, Tutuncu AC, Emre S, Altindas F, Kaya G. Pudendal Versus Caudal Block in Children Undergoing Hypospadias Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):610-5. doi: 10.1097/AAP.0000000000000447.
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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.
Guner Kaya, Prof. study director
Istanbul University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pudendal nerve block and caudal block in people with Pain, 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 2 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 26 Aug 2015. 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.
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 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 intensity measure (time frame: 24 hours). 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 NCT02390388, which also lists 2 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 26 Aug 2015.