Penile Blood Flow Characteristics Following Caudal or Penile Block

NCT ID: NCT04590859

Last Updated: 2021-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-07

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

The Aim of This Study is to Measure Blood Flow Before and After a Block

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Penile block

Patients undergoing procedure with penile block

Block performed

Intervention Type PROCEDURE

Comparing block performed with penile blood flow

LMA placement

Intervention Type DEVICE

Placement of LMA for airway securement

caudal block

Patients undergoing procedure with caudal block

Block performed

Intervention Type PROCEDURE

Comparing block performed with penile blood flow

LMA placement

Intervention Type DEVICE

Placement of LMA for airway securement

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Block performed

Comparing block performed with penile blood flow

Intervention Type PROCEDURE

LMA placement

Placement of LMA for airway securement

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

2 Years

Maximum Eligible Age

7 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Adam Adler MD, MS, FAAP

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Texas childrens Hospital

Houston, Texas, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

adam c adler, MD

Role: CONTACT

7864177529

paul austin, md

Role: CONTACT

832-824-5800

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Adam Adler, MD

Role: primary

832-824-5800

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H-48138

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.