Postoperative PainNCT04840654
Pudendal vs Caudal Block for Pediatric Penile Surgery
A study testing Caudal Block and Pudendal Block in people with Postoperative Pain, run by University of Chicago at 1 site in United States.
Trial summary
The study will compare recovery profile in children receiving pudendal blocks vs caudal analgesia for ambulatory circumcision or hypospadias repair in children between 6 months and 2 years. The subjects of the study will be randomized to receive either a caudal or a pudendal block. Read more about this study
- Who is it for?
- Ages 6 months to 3 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Caudal Block and Pudendal Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 2 Oct 2024
- 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 to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- - Children Aged 6 months -3 years
- Scheduled for elective outpatient circumcision or hypospadias repair
Who cannot join
- ASA classification ≥ 3
- emergency surgery
- history of a complex regional pain syndrome
- sacral dimple
- known vertebral spinal abnormalities, spinal dysraphism
- history of long-term analgesic use
Show all 12Show fewer
- use of any analgesic (e.g., an opioid medication, acetaminophen, or a nonsteroidal anti-inflammatory agent) within 24 hours before surgery
- history of renal insufficiency or a bleeding disorder
- concurrent additional surgery at another anatomic site
- being a ward of the state
- a non-English speaking patient or primary caregiver
- inability of the primary caregiver to comply with home instructions
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
The study will compare recovery profile in children receiving pudendal blocks vs caudal analgesia for ambulatory circumcision or hypospadias repair in children between 6 months and 2 years. The subjects of the study will be randomized to receive either a caudal or a pudendal block.
Read the detailed description
The study participation will begin on the day of surgery and end at the time of last surgical follow-up visit, approximately two weeks later. All procedure related, follow-up clinic visit and PACU data will be collected by the research team from the patient's EPIC record (demographic data, pain scores in the PACU, analgesic consumption, time to perform block, time to discharge, etc). Data pertaining to the recovery of patient at home will be collected via phone call or email to the caregiver of the child. Late complications will be identified by reviewing the follow-up surgical note.
Questionnaire Administration The physical Pain journal/questionnaires
The physical Pain journal/questionnaires will be handed out to the caregiver before discharge from the Post-Anesthesia Care Unit.
The caregiver will fill out pain scores at home in the Pain Journal. The pain scores used (FLACC and PPPM) have been extensively validated. In addition, written instructions for using the pain scores to guide pain management interventions at home will be provided. Prior to discharge, caregivers will also be educated by a member of the research team on pain evaluation using the pain score and pain management algorithm.
The caregiver will be asked to answer a short questionnaire (Postoperative Parent Survey) about their child pain in the first 24 hours after discharge from the hospital. The caregiver will receive a phone call from the research team 24-48 hours after discharge to retrieve the results of the Pain Journal and Postoperative Pain Survey.
Phone Calls Approximately 24-48 hours after the child is discharged from the hospital, a member of the study team will call the caregivers/parents to retrieve the journal responses and check on the health status of the child. During this call, if there are any adverse event that may be related to the block that was performed noted, this will be documented on the AE log and a follow-up phone call will be made approximately 7 days after to verify if the event has ended or is ongoing. Upon learning about any potential related AE, the investigator will determine its severity and relationship to the study procedure and report the event per University of Chicago guidelines.
- Conditions
- Postoperative Pain
- Being tested
- Caudal Block, Pudendal Block
- Keywords
- Nerve Block, Caudal Block, Pudendal Block, Circumcision, Hypospadias, Postoperative Analgesia, Opioid Consumption, Pain Score
- Medical subject headings
- Pain, Postoperative, Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal BlockProcedure or surgery
A caudal block is a procedure that will help lessen a child's pain after an operation.
100 subjects will be randomized to this block procedure.
Pudendal BlockProcedure or surgery
form of local anesthesia commonly used in the practice of obstetrics to relieve pain during the delivery of baby by forceps.
100 Subjects will be randomized to this block procedure.
| Study group | Role | What they receive |
|---|---|---|
| Caudal block | Active comparator | This group will receive the Caudal block during their operation (50 patients circumcision, 50 patients hypospadias). This group consist of 100 subjects Receives: Procedure: Caudal Block |
| Pudendal Block | Active comparator | This group will receive the Pudendal block during their operation (50 patients circumcision, 50 patients hypospadias). This group consist of 100 subjects Receives: Procedure: Pudendal Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic Consumption
Number of doses of analgesics in the recovery room and in the first 24 hours at home
Measured: 24 Hours
Secondary outcomes (5)
Postoperative Pain Scores
Analgesia will be evaluated based on the Face, Legs, Activity, Cry, Consolability (FLACC) Scale. This scale has a maximum score of 10 and a minimum score of 0, where the higher the score, the worse outcome. FLACC scores will be recorded in the PACU by the assigned recovery room nurses.
Measured: 2 Weeks
Block failure
Block failure (inability to place block, or block failure based on increase in HR or BP >20% in response to incision)
Measured: 2 Weeks
Intraoperative opioid consumption
Intraoperative opioid consumption during surgery
Measured: During Surgery
Time to place the block
The length of time it takes to perform the block on each subject
Measured: During Surgery
Time to first analgesic request at home
Time to first analgesic request at home
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start1 May 2021
- Primary completion2 Oct 2024
- Study completion2 Oct 2024
Why it stopped: Lack of funding and change of PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Model description
- Subjects will be randomized to 2 groups. One group will receive the Caudal block. The other group will receive the Pudendal block.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leili Khorassani, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840654
- Sponsor's protocol ID
- IRB20-1857
- Status last verified
- Jul 2025
- First submitted
- 6 Apr 2021
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pudendal vs Caudal Block for Pediatric Penile Surgery
- ClinicalTrials.gov ID
- NCT04840654
- Acronym / sponsor ID
- IRB20-1857
- Conditions
- Postoperative Pain
- Keywords
- Nerve Block, Caudal Block, Pudendal Block, Circumcision, Hypospadias, Postoperative Analgesia, Opioid Consumption, Pain Score
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding and change of PI
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 2 Oct 2024 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 12 Apr 2021 (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 study will compare recovery profile in children receiving pudendal blocks vs caudal analgesia for ambulatory circumcision or hypospadias repair in children between 6 months and 2 years. The subjects of the study will be randomized to receive either a caudal or a pudendal block.
Detailed description
The study participation will begin on the day of surgery and end at the time of last surgical follow-up visit, approximately two weeks later. All procedure related, follow-up clinic visit and PACU data will be collected by the research team from the patient's EPIC record (demographic data, pain scores in the PACU, analgesic consumption, time to perform block, time to discharge, etc). Data pertaining to the recovery of patient at home will be collected via phone call or email to the caregiver of the child. Late complications will be identified by reviewing the follow-up surgical note.
Questionnaire Administration The physical Pain journal/questionnaires
The physical Pain journal/questionnaires will be handed out to the caregiver before discharge from the Post-Anesthesia Care Unit.
The caregiver will fill out pain scores at home in the Pain Journal. The pain scores used (FLACC and PPPM) have been extensively validated. In addition, written instructions for using the pain scores to guide pain management interventions at home will be provided. Prior to discharge, caregivers will also be educated by a member of the research team on pain evaluation using the pain score and pain management algorithm.
The caregiver will be asked to answer a short questionnaire (Postoperative Parent Survey) about their child pain in the first 24 hours after discharge from the hospital. The caregiver will receive a phone call from the research team 24-48 hours after discharge to retrieve the results of the Pain Journal and Postoperative Pain Survey.
Phone Calls Approximately 24-48 hours after the child is discharged from the hospital, a member of the study team will call the caregivers/parents to retrieve the journal responses and check on the health status of the child. During this call, if there are any adverse event that may be related to the block that was performed noted, this will be documented on the AE log and a follow-up phone call will be made approximately 7 days after to verify if the event has ended or is ongoing. Upon learning about any potential related AE, the investigator will determine its severity and relationship to the study procedure and report the event per University of Chicago guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized to 2 groups. One group will receive the Caudal block. The other group will receive the Pudendal block.
| Arm | Type | Receives |
|---|---|---|
| Caudal block | Active comparator | Procedure: Caudal BlockThis group will receive the Caudal block during their operation (50 patients circumcision, 50 patients hypospadias). This group consist of 100 subjects |
| Pudendal Block | Active comparator | Procedure: Pudendal BlockThis group will receive the Pudendal block during their operation (50 patients circumcision, 50 patients hypospadias). This group consist of 100 subjects |
Who may qualify
- Ages
- 6 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- - Children Aged 6 months -3 years
- Scheduled for elective outpatient circumcision or hypospadias repair
Key exclusion criteria (12 listed)
- ASA classification ≥ 3
- emergency surgery
- history of a complex regional pain syndrome
- sacral dimple
- known vertebral spinal abnormalities, spinal dysraphism
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 |
|---|---|---|
| Caudal BlockA caudal block is a procedure that will help lessen a child's pain after an operation. 100 subjects will be randomized to this block procedure. | Procedure or surgery | Caudal block |
| Pudendal Blockform of local anesthesia commonly used in the practice of obstetrics to relieve pain during the delivery of baby by forceps. 100 Subjects will be randomized to this block procedure. | Procedure or surgery | Pudendal Block |
Primary outcome
Analgesic Consumption
Time frame: 24 Hours
Number of doses of analgesics in the recovery room and in the first 24 hours at home
5 secondary outcomes
Postoperative Pain Scores
Time frame: 2 Weeks
Block failure
Time frame: 2 Weeks
Intraoperative opioid consumption
Time frame: During Surgery
Time to place the block
Time frame: During Surgery
Time to first analgesic request at home
Time frame: 2 Weeks
Results and safety
The study was stopped early (reason given: Lack of funding and change of PI). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
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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.
Leili Khorassani, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caudal Block and Pudendal Block in people with Postoperative Pain, run by University of Chicago at 1 site in United States.
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 12 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: stopped early, as of the sponsor's last update on 24 Jul 2025. 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 United States. 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 was stopped early (reason given: Lack of funding and change of PI). Results are not available in the source record.
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?
Analgesic Consumption (time frame: 24 Hours). 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 24 Jul 2025.