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Paravertebral Versus Caudal Block in Pediatric PCNL

Primary Purpose

Kidney Stones, Percutaneous Nephrolithotomy

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Paravertebral
Caudal block
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Stones focused on measuring paravertebral block, caudal block, Percutaneous nephrolithotomy, pediatric

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assiut UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Paravertebral

Caudal

Arm Description

Ultrasound-guided thoracic paravertebral block

Caudal block

Outcomes

Primary Outcome Measures

Blood pressure during surgery in mmHg
Heart rate (beats/minute)
The concentration of sevoflurane in %
Postoperative pain using FLACC score

Secondary Outcome Measures

Full Information

First Posted
August 6, 2021
Last Updated
August 19, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05012215
Brief Title
Paravertebral Versus Caudal Block in Pediatric PCNL
Official Title
Ultrasound Guided Thoracic Paravertebral Block Versus Ultrasound Guided Caudal Epidural Block in Pediatric Patients Undergoing Percutaneous Nephrolithotomy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 19, 2021 (Actual)
Primary Completion Date
March 20, 2022 (Anticipated)
Study Completion Date
March 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stones, Percutaneous Nephrolithotomy
Keywords
paravertebral block, caudal block, Percutaneous nephrolithotomy, pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paravertebral
Arm Type
Experimental
Arm Description
Ultrasound-guided thoracic paravertebral block
Arm Title
Caudal
Arm Type
Active Comparator
Arm Description
Caudal block
Intervention Type
Procedure
Intervention Name(s)
Paravertebral
Intervention Description
Ultrasound-guided paravertebral block
Intervention Type
Procedure
Intervention Name(s)
Caudal block
Intervention Description
Caudal block
Primary Outcome Measure Information:
Title
Blood pressure during surgery in mmHg
Time Frame
through the surgery, an average of 2 hours
Title
Heart rate (beats/minute)
Time Frame
through the surgery, an average of 2 hours
Title
The concentration of sevoflurane in %
Time Frame
through the surgery, an average of 2 hours
Title
Postoperative pain using FLACC score
Time Frame
up to 12 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hany M. Osman, M.D.
Phone
+201002414591
Email
hanymeo@aun.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Fatma N. Mohamed, M.D.
Email
fatmanabil2012@gmail.com
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hany M. Osman, M.D.
Phone
+201002414591
Email
hanymeo@aun.edu.eg
First Name & Middle Initial & Last Name & Degree
Fatma N. Mohamed, M.D.
Email
fatmanabil2012@gmail.com
First Name & Middle Initial & Last Name & Degree
Mohamed Anwar, M.D.

12. IPD Sharing Statement

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Paravertebral Versus Caudal Block in Pediatric PCNL

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