Penile Blood Flow Characteristics Following Caudal or Penile Block

September 29, 2021 updated by: Adam Adler MD, MS, FAAP, Baylor College of Medicine
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: paul austin, md
  • Phone Number: 832-824-5800

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

males undergoing circumcision using penile or caudal

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Penile block
Patients undergoing procedure with penile block
Procedure: Block performed
Comparing block performed with penile blood flow
Device: LMA placement
Placement of LMA for airway securement
caudal block
Patients undergoing procedure with caudal block
Procedure: Block performed
Comparing block performed with penile blood flow
Device: LMA placement
Placement of LMA for airway securement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
penile blood flow
Time Frame: 20 minutes
assessment of changes using ultrasound to blood flow based on block performed
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

September 10, 2020

First Submitted That Met QC Criteria

October 15, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

September 30, 2021

Last Update Submitted That Met QC Criteria

September 29, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • H-48138

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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