Paravertebral Versus Caudal Block in Pediatric PCNL | NCT05012215

Studies
Paravertebral Versus Caudal Block in Pediatric PCNL

NCT05012215

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Aug 20, 2021Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Kidney Stones
Percutaneous Nephrolithotomy

Interventions

Paravertebral
Caudal block

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 19, 2021Actual

Primary Completion Date

Mar 20, 2022Estimated

Completion Date

Mar 20, 2022Estimated

First Submitted Date

Aug 6, 2021

First Submission Date that Met QC Criteria

Aug 16, 2021

First Posted Date

Aug 19, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2021

Last Update Posted Date

Aug 20, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hany Mostafa Esmaeil Osman, Principal Investigator, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To compare the efficacy of Ultrasound guided thoracic paravertebral block versus ultrasound guided caudal epidural block in pediatric patients undergoing percutaneous nephrolithotomy

Detailed Description

Percutaneous Nephrolithotomy (PCNL) is a commonly performed surgical procedure for complex upper renal tract calculi. Although the skin incision for PCNL appears small, the intensity of intraoperative and postoperative pain is significant owing to soft tissue injury.

Paravertebral block is the technique of injecting local anesthetics in a space immediately lateral to where the spinal nerves emerge from the intervertebral foramina. This technique is used increasingly for intra-operative and post-operative.

Caudal epidural block involves placing a needle through the sacral hiatus to deliver medications into the epidural space. This approach is used widely used for surgical anesthesia and analgesia in pediatric patients.

this work aims to compare the efficacy of Ultrasound guided thoracic paravertebral block versus ultrasound guided caudal epidural block in pediatric patients undergoing percutaneous nephrolithotomy

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Paravertebral	Experimental	Ultrasound-guided thoracic paravertebral block	Procedure: Paravertebral
Caudal	Active Comparator	Caudal block	Procedure: Caudal block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Paravertebral	Procedure	Ultrasound-guided paravertebral block	Paravertebral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood pressure during surgery in mmHg		through the surgery, an average of 2 hours
Heart rate (beats/minute)		through the surgery, an average of 2 hours
The concentration of sevoflurane in %		through the surgery, an average of 2 hours
Postoperative pain using FLACC score		up to 12 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing percutaneous nephrolithotomy

Exclusion Criteria:

Coagulation disorders
Infection at the site of injection
Allergy to the local anesthetics used
Spinal cord abnormalities or neurological deficits

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hany M. Osman, M.D.	Contact	+201002414591		hanymeo@aun.edu.eg
Fatma N. Mohamed, M.D.	Contact			fatmanabil2012@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut University	Recruiting	Asyut		71515	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D007669	Kidney Calculi

Ancestor Terms

ID	Term
D053040	Nephrolithiasis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

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