Paravertebral Versus Caudal Block in Pediatric PCNL

August 19, 2021 updated by: Hany Mostafa Esmaeil Osman, Assiut University

Ultrasound Guided Thoracic Paravertebral Block Versus Ultrasound Guided Caudal Epidural Block in Pediatric Patients Undergoing Percutaneous Nephrolithotomy

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Recruiting
        • Assiut University

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

1 year to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paravertebral
Ultrasound-guided thoracic paravertebral block
Procedure: Paravertebral
Ultrasound-guided paravertebral block
Active Comparator: Caudal
Caudal block
Procedure: Caudal block
Caudal block

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Assiut University

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)

August 19, 2021

Primary Completion (Anticipated)

March 20, 2022

Study Completion (Anticipated)

March 20, 2022

Study Registration Dates

First Submitted

August 6, 2021

First Submitted That Met QC Criteria

August 16, 2021

First Posted (Actual)

August 19, 2021

Study Record Updates

Last Update Posted (Actual)

August 20, 2021

Last Update Submitted That Met QC Criteria

August 19, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Paravertebral Caudal PCNL

Drug and device information, study documents

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

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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