- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05012215
Paravertebral Versus Caudal Block in Pediatric PCNL
Ultrasound Guided Thoracic Paravertebral Block Versus Ultrasound Guided Caudal Epidural Block in Pediatric Patients Undergoing Percutaneous Nephrolithotomy
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Assiut, Egypt, 71515
- Recruiting
- Assiut University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
Ultrasound-guided paravertebral block
|
Active Comparator: Caudal
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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