ClinicalTrials.gg
CompletedNCT03496740Updated Nov 27, 2018

Ultrasound Guided Penile Block vs Pudendal Block for Hypospadias

An interventional study of Penile Block and Pudendal Block in Postoperative Pain, sponsored by Kocaeli University. Completed at 1 site in Turkey. Open to male participants aged 1 Year to 10 Years. Per ClinicalTrials.gov, last updated 2018-11-27.

Sponsored by Kocaeli University · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
1 Year to 10 Years
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 26 studies in Pain, Postoperative by Kocaeli University — 6 open to participants now, 6 under way, none of them phase 3. Pain, Postoperative · Kocaeli University.

Enrollment
21st of 21
36 · median 60
Started
2018
with 5 others
No phase
20 of 26
5 open now
Registered
5th of 26
by date

Among the 26 studies in Pain, Postoperative by Kocaeli University, this one is the 21st largest by enrollment of the 21 interventional ones that give a count, is one of 6 that started in 2018, is one of 20 with no phase, and was the 5th registered.

Pain, Postoperative

5,644 studies on the registry are indexed under Pain, Postoperative; 1,229 are open to participants now.

Browse Pain, Postoperative studies →

Open to participants now

6 of the 26 studies in Pain, Postoperative by Kocaeli University are open now, in 1 country. Recruiting first, the newest first:

1 more — sign in →

By country, each count listing its studies:

All 6 open studies →

Where they have run

Who these studies take

Of the 678 Pain, Postoperative studies recruiting now, 241 (36%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.

This study: 1 Year to 10 Years · male · no healthy volunteers.

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02

Study summary

Pain after hypospadias surgery is a challenging issue to solve for anesthesists. Many different analgesia techniques were defined in literature for this purpose. The investigators have implemented application of ultrasound guided dorsal penile nerve block into practice for these type of surgeries. Main purpose of this study is to compare the efficacy of nerve stimulator guided pudendal nerve block with ultrasound guided dorsal penile nerve block for postoperative analgesia after hypospadias surgery.

03

Conditions studied

  • Postoperative Pain

Keywords

  • Postoperative pain
  • Ultrasound
  • Dorsal Penile Nerve Block
  • Pudendal Block
  • Hypospadias
04

Who can participate

Ages eligible
1 Year to 10 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1 to 10 years of age
  • Undergoing elective hypospadias surgery

Exclusion criteria

Exclusion Criteria:

  • infection of the skin at the site of needle puncture area
  • patients with known allergies to any of the study drugs
  • coagulopathy
  • Patients with neurological disorders
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Active comparator
    Penile Block

    Ultrasound guided dorsal penile nerve block will be administered after general anesthesia. 0,25% Bupivacaine 0,5ml/kg (max. 20ml) will be used for the blocks

    Procedure: Penile Block · Drug: Bupivacaine (Block Drug)

  • Active comparator
    Pudendal Block

    Nerve stimulator-guided pudendal block. 0,25% Bupivacaine 0,5ml/kg (max. 20ml) will be used for the blocks

    Procedure: Pudendal Block · Drug: Bupivacaine (Block Drug)

Interventions

  • ProcedurePenile Block

    Ultrasound guided dorsal penile nerve block will be done to this group of patients preoperatively, under general anesthesia. 0,25% Bupivacaine 0,5ml/kg (max. 20ml)

  • ProcedurePudendal Block

    Nerve stimulation guided bilateral pudendal block will be done to this group of patients preoperatively, under general anesthesia. 0,25% Bupivacaine 0,5ml/kg (max. 20ml)

  • Block drug

06

What researchers measure

Primary outcomes

  1. Time to first analgesic

    First need for rescue analgesic after the surgery will be recorded

    Time frame: postoperative 7 day

Secondary outcomes

  1. Pain Scores

    FLACC scale will be used. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.

    Time frame: postoperative 48 hour

07

Study locations

1 site
  • Kocaeli University Hospital
    İzmit, Kocaeli 41340, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2018 to primary completion in Nov 2018, 7 months.

Of 2,094 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 7 months is below that.

Counting every sponsor, half of 2,107 studies reached it within 11 months; a quarter within 6 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 5, 2018
First posted
Apr 12, 2018
StartActual
Apr 15, 2018
Primary completionActual
Nov 23, 2018
CompletionActual
Nov 23, 2018
Last update
Nov 27, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03496740
Lead sponsor
Kocaeli University
Responsible party
Can AKSU (Assistant Professor, Kocaeli University) — Principal investigator
First posted
Apr 12, 2018
Start date
Apr 15, 2018
Primary completion
Nov 23, 2018
Completion
Nov 23, 2018
Last update
Nov 27, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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