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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis
• Nephrolithotomy
• Renal Stone

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