The Aim of This Study is to Measure Blood Flow Before and After a BlockNCT04590859
Penile Blood Flow Characteristics Following Caudal or Penile Block
An observational study of The Aim of This Study is to Measure Blood Flow Before and After a Block, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Pediatric urologic surgery is generally accompanied by use of a caudal or penile block for analgesia. A caudal block is performed by injecting local anesthetic in the low epidural space while a penile block is performed by injecting local anesthetic above the pubic symphysis. Read more about this study
- Who is it for?
- Ages 2 to 7 years, men only
- Conditions the study is for
- The Aim of This Study is to Measure Blood Flow Before and After a Block
- What is being tested?
- Block performed and LMA placement
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2020to 31 Dec 2021
- 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 2 to 7 years
- Men only
- No healthy volunteers
- Child
Study population: males undergoing circumcision using penile or caudal
Who may be able to join
- Children ages <7 years undergoing circumcision at TCH Penile or Caudal block to be performed at discretion of anesthesiology/Urology providers
- ASA classification1,2
- use of laryngeal mask airway
Who cannot join
- Previous cardiac surgery
- Antihypertensive medication
- requirement for intravenous anesthetic
- ASA classification non 1,2
- parental refusal of participation parental refusal of block
- patients requiring intubation
Trial locations and contacts
1 site in 1 country.
paul austin, md contact
United States1 site, 1 recruiting
- Recruiting
Texas childrens Hospital
Houston, Texas, 77030
Adam Adler, MD, 832-824-5800, axadler@texaschildrens.org
About this study
Pediatric urologic surgery is generally accompanied by use of a caudal or penile block for analgesia. A caudal block is performed by injecting local anesthetic in the low epidural space while a penile block is performed by injecting local anesthetic above the pubic symphysis. Local anesthetic in the epidural space is known to caudal vasodilation interiorly. It is unknown as to whether this vasodilation results in alteration in flow to the penile tissue and potentially changes tissue characteristics. The aim of this study is to measure blood ultrasound velocity in the dorsal penile artery and vein before and after a block.
Read the detailed description
Pediatric urologic surgery is generally accompanied by use of a caudal or penile block for analgesia. A caudal block is performed by injecting local anesthetic in the low epidural space while a penile block is performed by injecting local anesthetic above the pubic symphysis. Local anesthetic in the epidural space is known to caudal vasodilation interiorly. It is unknown as to whether this vasodilation results in alteration in flow to the penile tissue and potentially changes tissue characteristics. The aim of this study is to measure blood ultrasound velocity in the dorsal penile artery and vein before and after a block.
- Being tested
- Block performed, LMA placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Block performedProcedure or surgery
Comparing block performed with penile blood flow
LMA placementDevice
Placement of LMA for airway securement
| Study group | Role | What they receive |
|---|---|---|
| Penile block | Patients undergoing procedure with penile block Receives: Procedure: Block performed; Device: LMA placement | |
| caudal block | Patients undergoing procedure with caudal block Receives: Procedure: Block performed; Device: LMA placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
penile blood flow
assessment of changes using ultrasound to blood flow based on block performed
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start7 Sep 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Aim of This Study is to Measure Blood Flow Before and After a BlockStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Adler MD, MS, FAAP, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590859
- Sponsor's protocol ID
- H-48138
- Status last verified
- Sep 2021
- First submitted
- 10 Sep 2020
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penile Blood Flow Characteristics Following Caudal or Penile Block
- ClinicalTrials.gov ID
- NCT04590859
- Acronym / sponsor ID
- H-48138
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 19 Oct 2020 (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.
Pediatric urologic surgery is generally accompanied by use of a caudal or penile block for analgesia. A caudal block is performed by injecting local anesthetic in the low epidural space while a penile block is performed by injecting local anesthetic above the pubic symphysis. Local anesthetic in the epidural space is known to caudal vasodilation interiorly. It is unknown as to whether this vasodilation results in alteration in flow to the penile tissue and potentially changes tissue characteristics. The aim of this study is to measure blood ultrasound velocity in the dorsal penile artery and vein before and after a block.
Detailed description
Pediatric urologic surgery is generally accompanied by use of a caudal or penile block for analgesia. A caudal block is performed by injecting local anesthetic in the low epidural space while a penile block is performed by injecting local anesthetic above the pubic symphysis. Local anesthetic in the epidural space is known to caudal vasodilation interiorly. It is unknown as to whether this vasodilation results in alteration in flow to the penile tissue and potentially changes tissue characteristics. The aim of this study is to measure blood ultrasound velocity in the dorsal penile artery and vein before and after a block.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Penile block | – | Procedure: Block performed, Device: LMA placementPatients undergoing procedure with penile block |
| caudal block | – | Procedure: Block performed, Device: LMA placementPatients undergoing procedure with caudal block |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- males undergoing circumcision using penile or caudal
Key inclusion criteria (3 listed)
- Children ages <7 years undergoing circumcision at TCH Penile or Caudal block to be performed at discretion of anesthesiology/Urology providers
- ASA classification1,2
- use of laryngeal mask airway
Key exclusion criteria (6 listed)
- Previous cardiac surgery
- Antihypertensive medication
- requirement for intravenous anesthetic
- ASA classification non 1,2
- parental refusal of participation parental refusal of block
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 |
|---|---|---|
| Block performedComparing block performed with penile blood flow | Procedure or surgery | Penile block, caudal block |
| LMA placementPlacement of LMA for airway securement | Device | Penile block, caudal block |
Primary outcome
penile blood flow
Time frame: 20 minutes
assessment of changes using ultrasound to blood flow based on block performed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Individual participant dataSharing planned: Undecided
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.
paul austin, md contact
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 The Aim of This Study is to Measure Blood Flow Before and After a Block, run by Baylor College of Medicine 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 30 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact adam c adler, MD (7864177529, adam.adler@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
penile blood flow (time frame: 20 minutes). 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 30 Sep 2021.