Erector Spinae Versus Paravertebral in Pediatric PCNL | NCT05589649

Studies
Erector Spinae Versus Paravertebral in Pediatric PCNL

NCT05589649

Sponsor

Assiut University

Status

Completed

Last Update Posted

Jan 10, 2024Actual

Enrollment

56Actual

Phase

Not Applicable

Conditions

Renal Stone
Percutaneous
Nephrolithotomy

Interventions

Erector spinae plane block
Paravertebral 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

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 26, 2022Actual

Primary Completion Date

Sep 27, 2023Actual

Completion Date

Dec 27, 2023Actual

First Submitted Date

Oct 18, 2022

First Submission Date that Met QC Criteria

Oct 18, 2022

First Posted Date

Oct 21, 2022Actual

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

Jan 9, 2024

Last Update Posted Date

Jan 10, 2024Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To compare the efficacy of ultrasound-guided erector spinae plane block versus ultrasound-guided paravertebral 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.

Erector spinae plane (ESP) block is an interfascial block that was first described by Forero et al. in 2016. It can be performed by injecting the local anesthetic in the deep interfascial plane of the erector spinae muscle to provide both visceral and somatic analgesia with a sensory level from T2-4 to L1-2.

. 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.

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

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Erector spinae plane block	Experimental	Ultrasound-guided erector spinae plane block	Procedure: Erector spinae plane block
Paravertebral	Experimental	Ultrasound-guided thoracic paravertebral block	Procedure: Paravertebral block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Erector spinae plane block	Procedure	Ultrasound-guided erector spinae plane block	Erector spinae plane block

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total consumption of nalbuphine		The first 24 hours postoperatively
Time to first rescue analgesia		The first 24 hours postoperatively

Secondary Outcomes

Measure	Description	Time Frame
The concentration of sevoflurane in percent		Through the surgery, an average of 2 hours
Systolic, diastolic, and mean blood pressure during surgery in mmHg		Through the surgery, an average of 2 hours

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

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

Condition Browse Module

MeSH Terms

ID	Term
D053040	Nephrolithiasis

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

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Browse Branches

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