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NCT05589649 Clinical Trial

Erector Spinae Versus Paravertebral in Pediatric PCNL

Renal Stone Clinical Trial

Official title:
Ultrasound-guided Erector Spinae Plane Block Versus Ultrasound-guided Thoracic Paravertebral Block in Pediatric Patients Undergoing Percutaneous Nephrolithotomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05589649
Other study ID # ESP versus Paravertebral
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 26, 2022
Est. completion date December 27, 2023

Study information
Verified date January 2024
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date December 27, 2023
Est. primary completion date September 27, 2023
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

Related Conditions & MeSH terms

Intervention

Procedure:
• Erector spinae plane block
Ultrasound-guided erector spinae plane block
• Paravertebral block
Ultrasound-guided paravertebral 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 Total consumption of nalbuphine The first 24 hours postoperatively
Primary Time to first rescue analgesia The first 24 hours postoperatively
Secondary The concentration of sevoflurane in percent Through the surgery, an average of 2 hours
Secondary Systolic, diastolic, and mean blood pressure during surgery in mmHg Through the surgery, an average of 2 hours
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