Caudal BlockNCT06862271
Comparison of Caudal Block Combined With General Anesthesia and Penile Block and Intravenous Fentanyl in Pediatric Surgeries
An observational study of Caudal Block and Pediatric Urologic Surgeries, run by Miray Gözde Özdemir at 1 site in Turkey (Türkiye).
Trial summary
Urogenital surgery is one of the most frequently performed surgical procedures in the pediatric patient population. There is no consensus on which analgesic method is most effective for pain control in these patients. Read more about this study
- Who is it for?
- Ages 4 months to 12 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Caudal Block, Pediatric Urologic Surgeries, Fentanyl
- What is being tested?
- Group 1 ( Caudal block group ) and Group 2 (Penile block and IV Fentanyl group)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 19 Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 4 months to 12 years
- Men only
- Healthy volunteers accepted
- Child
Study population: 4 months to 12 years old male pediatric population
Who may be able to join
- 4 months - 12 years old male patient
- Acceptance of participation in the study
- Patients Planned for Urogenital Surgery
- ASA I-II Patients
Who cannot join
- <4 months, >12 years male patient
- Female patient
- Not accepted to be included in the study
- ASA status III-IV
- History of bleeding disorder
- Spinal cord disease
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- Obstructive sleep apnea
- Developmental delay
- Behavioral disorder
- Allergy to any drug in the protocol
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Yenimahalle, Ankara, 06100
About this study
Official title: Opioid-Free Caudal Block Versus Opioid-Supplemented Dorsal Penile Nerve Block Under General Anesthesia for Postoperative Analgesia and Emergence Delirium in Pediatric Urogenital Surgery
Urogenital surgery is one of the most frequently performed surgical procedures in the pediatric patient population. There is no consensus on which analgesic method is most effective for pain control in these patients. In clinical practice, if there are no contraindications, caudal block or penile block combined with intravenous fentanyl can be preferred as an analgesic method.
In this study, the results of these two analgesia methods will be compared with the research.Randomly selected participants will be compared by looking at parameters such as postoperative questionnaire results, walking time and urination time.
- Being tested
- Group 1 ( Caudal block group ), Group 2 (Penile block and IV Fentanyl group)
- Keywords
- pediatric urologic surgeries, pediatric delirium, caudal block, penile block, FLACC Scale, PAED Scale
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 ( Caudal block group )Procedure or surgery
In the caudal block group, after the induction of caudal block with investigations, 0.2% bupivacaine will be applied to the epidural space in a volume of 0.8 mL/kg and a maximum of 20 mL will be injected into the epidural space and the surgical incision will be made at the 15th minute. For participants after surgery, Pediatric Anesthesia Emergence Delirium (PAED), Face Leg Activity Cry Consolability (FLACC) scales will be recorded, and for parental satisfaction, the LIKERT scale will be used. In addition, the child's walking time, first urination time, and need for additional painkillers will be questioned and recorded.
Group 2 (Penile block and IV Fentanyl group)Procedure or surgery
In the penile block and IV fentanyl group, 1 µg/kg fentanyl will be administered by the investigations and 5 minutes later, penile block will be performed using 0.25% bupivacaine at a dose of 0.2 mL/kg. For participants after surgery, Pediatric Anesthesia Emergence Delirium (PAED), Face Leg Activity Cry Consolability (FLACC) scales will be recorded, and for parental satisfaction, the LIKERT scale will be used. In addition, the child's walking time, first urination time, and need for additional painkillers will be questioned and recorded.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 ( Caudal block group ) | In the caudal block group, after the induction of caudal block with investigations, 0.2% bupivacaine will be applied to the epidural space in a volume of 0.8 mL/kg and a maximum of 20 mL will be injected into the epidural space and the surgical incision will be made at the 15th minute. Receives: Procedure: Group 1 ( Caudal block group ) | |
| Group 2 (Penile block and IV Fentanyl group) | In the penile block and IV fentanyl group, 1 µg/kg fentanyl will be administered by the investigations and 5 minutes later, penile block will be performed using 0.25% bupivacaine at a dose of 0.2 mL/kg. Receives: Procedure: Group 2 (Penile block and IV Fentanyl group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Anesthesia Emergence Delirium (PAED) Scale
The PAED scale will be used to assess post-anesthesia emergence agitation. This scale was defined in 2004 and is considered the standard for diagnosing emergence agitation.
The scale, consisting of five statements (from "child makes eye contact" to "child cannot be comforted") is rated from 1 to 4, with a maximum score of 20.
Patients are observed for each of the 5 symptoms of delirium. After an observation is completed, the clinician subjectively scores the severity of that delirium symptom using the Lickert scale ("not at all," "only a little," "quite a bit," "very much," and "extremely"). A total score of 10 or more may be consistent with delirium urgent.
As the score increases, a score of ≥10 points indicates 64% sensitivity and 86% specificity for delirium, while a score of >12 points provides 100% sensitivity and 94.5% specificity for the diagnosis of emergency delirium (ED).
Measured: The first evaluation will be made after extubation, the second evaluation will be made at the 15th minute after surgery.
Secondary outcomes (2)
Face Leg Activity Cry Consolability (FLACC) Scale
The FLACC scale will be used to assess pain. Developed as a tool for evaluating postoperative pain in children, this scale is one of the most widely known and commonly recommended pain measurement scales.
Each category in the "FLACC" (Face, Legs, Activity, Cry, Consolability) pain assessment scale is evaluated between 0-2, Total score varies between 0 and 10.
A score of 0 indicates that the child is calm and relaxed, a score of 1-3 indicates that the child is mildly disturbed, a score of 4-6 indicates that the child is in moderate pain, a score of 7-10 indicates that the child is significantly disturbed, in pain, or both.
Measured: The first evaluation will be made after extubation, the second evaluation will be made at the 15th minute after surgery.
LİKERT Scale
The LIKERT scale will be used to assess the satisfaction of the patient and his/her parents. The Likert scale is a one-dimensional scale used to collect the opinions of the participants. In our study, a 5-point Likert scale will be used. The patient will be visited after the surgery, and the satisfaction of the patient and his/her relatives in the postoperative period will be questioned. 1) Not at all satisfied 2) Somewhat satisfied 3) Moderate 4) Very satisfied, 5) Excellent
When comparing the groups, it will be evaluated that a higher LIKERT score constitutes 'better satisfaction'.
Measured: 24th hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Apr 2025
- Primary completion28 Nov 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caudal BlockStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Miray Gözde Özdemir
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Miray Gözde Özdemir, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862271
- Sponsor's protocol ID
- 102
- Status last verified
- May 2026
- First submitted
- 28 Feb 2025
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid-Free Caudal Block Versus Opioid-Supplemented Dorsal Penile Nerve Block Under General Anesthesia for Postoperative Analgesia and Emergence Delirium in Pediatric Urogenital Surgery
- ClinicalTrials.gov ID
- NCT06862271
- Acronym / sponsor ID
- 102
- Keywords
- pediatric urologic surgeries, pediatric delirium, caudal block, penile block, FLACC Scale, PAED Scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Miray Gözde ÖzdemirOther government
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 6 Mar 2025 (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.
Urogenital surgery is one of the most frequently performed surgical procedures in the pediatric patient population. There is no consensus on which analgesic method is most effective for pain control in these patients. In clinical practice, if there are no contraindications, caudal block or penile block combined with intravenous fentanyl can be preferred as an analgesic method.
In this study, the results of these two analgesia methods will be compared with the research.Randomly selected participants will be compared by looking at parameters such as postoperative questionnaire results, walking time and urination time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 ( Caudal block group ) | – | Procedure: Group 1 ( Caudal block group )In the caudal block group, after the induction of caudal block with investigations, 0.2% bupivacaine will be applied to the epidural space in a volume of 0.8 mL/kg and a maximum of 20 mL will be injected into the epidural space and the surgical incision will be made at the 15th minute. |
| Group 2 (Penile block and IV Fentanyl group) | – | Procedure: Group 2 (Penile block and IV Fentanyl group)In the penile block and IV fentanyl group, 1 µg/kg fentanyl will be administered by the investigations and 5 minutes later, penile block will be performed using 0.25% bupivacaine at a dose of 0.2 mL/kg. |
Who may qualify
- Ages
- 4 months to 12 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 4 months to 12 years old male pediatric population
Key inclusion criteria (4 listed)
- 4 months - 12 years old male patient
- Acceptance of participation in the study
- Patients Planned for Urogenital Surgery
- ASA I-II Patients
Key exclusion criteria (10 listed)
- <4 months, >12 years male patient
- Female patient
- Not accepted to be included in the study
- ASA status III-IV
- History of bleeding disorder
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 |
|---|---|---|
| Group 1 ( Caudal block group )In the caudal block group, after the induction of caudal block with investigations, 0.2% bupivacaine will be applied to the epidural space in a volume of 0.8 mL/kg and a maximum of 20 mL will be injected into the epidural space and the surgical incision will be made at the 15th minute. For participants after surgery, Pediatric Anesthesia Emergence Delirium (PAED), Face Leg Activity Cry Consolability (FLACC) scales will be recorded, and for parental satisfaction, the LIKERT scale will be used. In addition, the child's walking time, first urination time, and need for additional painkillers will be questioned and recorded. | Procedure or surgery | Group 1 ( Caudal block group ) |
| Group 2 (Penile block and IV Fentanyl group)In the penile block and IV fentanyl group, 1 µg/kg fentanyl will be administered by the investigations and 5 minutes later, penile block will be performed using 0.25% bupivacaine at a dose of 0.2 mL/kg. For participants after surgery, Pediatric Anesthesia Emergence Delirium (PAED), Face Leg Activity Cry Consolability (FLACC) scales will be recorded, and for parental satisfaction, the LIKERT scale will be used. In addition, the child's walking time, first urination time, and need for additional painkillers will be questioned and recorded. | Procedure or surgery | Group 2 (Penile block and IV Fentanyl group) |
Primary outcome
Pediatric Anesthesia Emergence Delirium (PAED) Scale
Time frame: The first evaluation will be made after extubation, the second evaluation will be made at the 15th minute after surgery.
The PAED scale will be used to assess post-anesthesia emergence agitation. This scale was defined in 2004 and is considered the standard for diagnosing emergence agitation. The scale, consisting of five statements (from "child makes eye contact" to "child cannot be comforted") is rated from 1 to 4, with a maximum score of 20. Patients are observed for each of the 5 symptoms of delirium. After an observation is completed, the clinician subjectively scores the severity of that delirium symptom using the Lickert scale ("not at all," "only a little," "quite a bit," "very much," and "extremely"). A total score of 10 or more may be consistent with delirium urgent. As the score increases, a score of ≥10 points indicates 64% sensitivity and 86% specificity for delirium, while a score of >12 points provides 100% sensitivity and 94.5% specificity for the diagnosis of emergency delirium (ED).
2 secondary outcomes
Face Leg Activity Cry Consolability (FLACC) Scale
Time frame: The first evaluation will be made after extubation, the second evaluation will be made at the 15th minute after surgery.
LİKERT Scale
Time frame: 24th hour after surgery
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 27 May 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caudal Block and Pediatric Urologic Surgeries, run by Miray Gözde Özdemir at 1 site in Turkey (Türkiye).
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 4 inclusion and 10 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 27 May 2026. 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 Turkey (Türkiye). 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?
Pediatric Anesthesia Emergence Delirium (PAED) Scale (time frame: The first evaluation will be made after extubation, the second evaluation will be made at the 15th minute after surgery.). 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 27 May 2026.