Penile Blood Flow Characteristics Following Caudal or Penile Block

• Conditions: The Aim of This Study is to Measure Blood Flow Before and After a Block
• Interventions: Procedure: Block performed; Device: LMA placement

• Registration Number: NCT04590859
• Lead Sponsor: Baylor College of Medicine

Brief 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. 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 Timeline

• Study Start: 2020-09-07
• Study First Submitted: 2020-09-10
• Study First Submitted QC: 2020-10-15
• Study First Posted: 2020-10-19
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-29
• Last Update Posted: 2021-09-30
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 25

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Penile block	LMA placement	Patients undergoing procedure with penile block
Penile block	Block performed	Patients undergoing procedure with penile block
caudal block	Block performed	Patients undergoing procedure with caudal block
caudal block	LMA placement	Patients undergoing procedure with caudal block

Primary Outcome Measures

Name	Time	Method
penile blood flow	20 minutes	assessment of changes using ultrasound to blood flow based on block performed

Trial Locations

Locations (1)

Texas childrens Hospital; 🇺🇸 Houston, Texas, United States