AzTrials
AzTrials

HypospadiasPhase 4NCT05708989

Caudal vs. Pudendal Block in Peds GU

A Phase 4 study testing Caudal Block, Ultrasound-guided Pudendal Block and Injectable 1 ml/kg of 0.25% ropivacaine with 1mcg/kg dexmedetomidine in people with Hypospadias and Penile Torsion, run by University Hospitals Cleveland Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This study will compare two techniques to minimize pain during and after penile surgery in children undergoing certain urologic surgeries. These two approaches include the caudal nerve block and the pudendal nerve block. Read more about this study

Who is it for?
Ages 6 months to 3 years, men only
Conditions the study is for
Hypospadias, Penile Torsion, Chordee
What is being tested?
Caudal Block, Ultrasound-guided Pudendal Block and Injectable 1 ml/kg of 0.25% ropivacaine with 1mcg/kg dexmedetomidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
6 Mar 2023to May 2025
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 6 months to 3 years
  • Men only
  • No healthy volunteers
  • Child

Who may be able to join

  • Undergoing penile genitourinary surgery
  • ASA class 1-3

Who cannot join

  • Female patients
  • Male children <6 months or >/= 3 years of age
  • ASA class >3
  • Surgery at satellite location (non-Prentiss)
  • Concurrent non-lower GU tract surgery
  • Sacrospinal abnormality
Show all 10Show fewer
  • History of chronic pain requiring opioid analgesics
  • Inability to tolerate and receive acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), alpha-2 agonists, or local anesthetics
  • History of malignant hyperthermia
  • History of coagulopathy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UH Rainbow Babies and Children's Hospital

    Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: Caudal vs. Pudendal Block for Early Postoperative Pain Control in a Pediatric Population Undergoing Lower Genitourinary Surgery

This study will compare two techniques to minimize pain during and after penile surgery in children undergoing certain urologic surgeries. These two approaches include the caudal nerve block and the pudendal nerve block.

Being tested
Caudal Block, Ultrasound-guided Pudendal Block, Injectable 1 ml/kg of 0.25% ropivacaine with 1mcg/kg dexmedetomidine, Injection of 0.5 ml/kg per side of injectable 0.2-0.3% ropivacaine with 0.5 mcg/kg dexmetomedine.
Keywords
caudal block, pudendal block, regional anesthesia
Medical subject headings
Hypospadias, Phimosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Caudal BlockProcedure or surgery

    Injectable 1 ml/kg of 0.25% ropivacaine with 1mcg/kg dexmedetomidine into caudal spinal space. First attempt will be landmark-guided into the caudal spine region. Subsequent attempt(s) may be done using ultrasound.

  • Ultrasound-guided Pudendal BlockProcedure or surgery

    Injection of 0.5 ml/kg per side of injectable 0.2-0.3% ropivacaine with 0.5 mcg/kg dexmetomedine. Ultrasound-guided injection into each pudendal nerve region through skin of buttocks.

  • Injectable 1 ml/kg of 0.25% ropivacaine with 1mcg/kg dexmedetomidineDrug

    Injectable 1 ml/kg of 0.25% ropivacaine with 1mcg/kg dexmedetomidine into caudal spinal space. First attempt will be landmark-guided into the caudal spine region. Subsequent attempt(s) may be done using ultrasound.

  • Injection of 0.5 ml/kg per side of injectable 0.2-0.3% ropivacaine with 0.5 mcg/kg dexmetomedine.Drug

    Injection of 0.5 ml/kg per side of injectable 0.2-0.3% ropivacaine with 0.5 mcg/kg dexmetomedine. Ultrasound-guided injection into each pudendal nerve region through skin of buttocks.

Study groups in NCT05708989
Study groupRoleWhat they receive
Caudal BlockActive comparatorPatients will receive a caudal block prior to surgery.
Receives: Procedure: Caudal Block; Drug: Injectable 1 ml/kg of 0.25% ropivacaine with 1mcg/kg dexmedetomidine
Pudendal BlockExperimentalPatients will receive a pudendal block prior to surgery.
Receives: Procedure: Ultrasound-guided Pudendal Block; Drug: Injection of 0.5 ml/kg per side of injectable 0.2-0.3% ropivacaine with 0.5 mcg/kg dexmetomedine.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rescue Narcotic Administration

    Dose (mg) of postoperative rescue opioid

    Measured: During post-operative in-hospital recovery, approximately 1 hour

Secondary outcomes (4)

  1. Non-Narcotic Rescue Administration at 24 hours

    Dose (mg) of non-narcotic rescue medication

    Measured: During first day after surgery, approximately 24 hours

  2. Non-Narcotic Rescue Administration at 48 hours

    Dose (mg) of non-narcotic rescue medication

    Measured: During second day after surgery, approximately 48 hours

  3. Non-Narcotic Rescue Administration at 72 hours

    Dose (mg) of non-narcotic rescue medication

    Measured: During third day after surgery, approximately 72 hours

  4. Number of participants with at least one adverse event (AE) as measured by patient report

    Adverse events will include any AE related to study procedure

    Measured: End of study, up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2023
  2. Study start6 Mar 2023
  3. Primary completionFeb 2025 (estimated)
  4. Study completionMay 2025 (estimated)

Why it stopped: PI leaving institution

Resources

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05708989
Sponsor's protocol ID
STUDY20220033
Status last verified
Jul 2024
First submitted
23 Jan 2023
Last updated
26 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wren AA, Ross AC, D'Souza G, Almgren C, Feinstein A, Marshall A, Golianu B. Multidisciplinary Pain Management for Pediatric Patients with Acute and Chronic Pain: A Foundational Treatment Approach When Prescribing Opioids. Children (Basel). 2019 Feb 21;6(2):33. doi: 10.3390/children6020033.

    PubMed 30795645

  • Vargas A, Sawardekar A, Suresh S. Updates on pediatric regional anesthesia safety data. Curr Opin Anaesthesiol. 2019 Oct;32(5):649-652. doi: 10.1097/ACO.0000000000000768.

    PubMed 31415045

  • Wiegele M, Marhofer P, Lonnqvist PA. Caudal epidural blocks in paediatric patients: a review and practical considerations. Br J Anaesth. 2019 Apr;122(4):509-517. doi: 10.1016/j.bja.2018.11.030. Epub 2019 Feb 1.

    PubMed 30857607

  • Okoro C, Huang H, Cannon S, Low D, Liston DE, Richards MJ, Lendvay TS. The pudendal nerve block for ambulatory urology: What's old is new again. A quality improvement project. J Pediatr Urol. 2020 Oct;16(5):594.e1-594.e7. doi: 10.1016/j.jpurol.2020.07.025. Epub 2020 Jul 24.

    PubMed 32819811

  • Shah UJ, Nguyen D, Karuppiaah N, Martin J, Sehmbi H. Efficacy and safety of caudal dexmedetomidine in pediatric infra-umbilical surgery: a meta-analysis and trial-sequential analysis of randomized controlled trials. Reg Anesth Pain Med. 2021 May;46(5):422-432. doi: 10.1136/rapm-2020-102024. Epub 2021 Jan 15.

    PubMed 33452203

  • Gaudet-Ferrand I, De La Arena P, Bringuier S, Raux O, Hertz L, Kalfa N, Sola C, Dadure C. Ultrasound-guided pudendal nerve block in children: A new technique of ultrasound-guided transperineal approach. Paediatr Anaesth. 2018 Jan;28(1):53-58. doi: 10.1111/pan.13286. Epub 2017 Dec 5.

    PubMed 29205687

  • Kendigelen 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

  • 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 24257391

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Caudal Block, Ultrasound-guided Pudendal Block and Injectable 1 ml/kg of 0.25% ropivacaine with 1mcg/kg dexmedetomidine in people with Hypospadias and Penile Torsion, run by University Hospitals Cleveland Medical Center 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 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: withdrawn, as of the sponsor's last update on 26 Jul 2024. 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.

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 was withdrawn before enrolling participants, so there are no results.

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?

Rescue Narcotic Administration (time frame: During post-operative in-hospital recovery, approximately 1 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 NCT05708989, which also lists 8 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 Jul 2024; AzTrials last refreshed its copy on 2 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in