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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05012215
Other study ID # Paravertebral Caudal PCNL
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 19, 2021
Est. completion date March 20, 2022

Study information

Verified date August 2021
Source Assiut University
Contact Hany M. Osman, M.D.
Phone +201002414591
Email hanymeo@aun.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date March 20, 2022
Est. primary completion date March 20, 2022
Accepts healthy volunteers No
Gender All
Age group 2 Years to 12 Years
Eligibility 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 Design


Intervention

Procedure:
Paravertebral
Ultrasound-guided paravertebral block
Caudal block
Caudal block

Locations

Country Name City State
Egypt Assiut University Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

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