Erector Spinae Versus Paravertebral in Pediatric PCNL

Sponsor

Assiut University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05589649

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the efficacy of ultrasound-guided erector spinae plane block versus ultrasound-guided paravertebral block in pediatric patients undergoing percutaneous nephrolithotomy

Condition or Disease	Intervention/Treatment	Phase
Renal Stone Percutaneous Nephrolithotomy	Procedure: Erector spinae plane block Procedure: Paravertebral block	N/A

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.

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 26, 2022

Anticipated Primary Completion Date :

Sep 27, 2023

Anticipated Study Completion Date :

Oct 27, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Erector spinae plane block Ultrasound-guided erector spinae plane block	Procedure: Erector spinae plane block Ultrasound-guided erector spinae plane block
Experimental: Paravertebral Ultrasound-guided thoracic paravertebral block	Procedure: Paravertebral block Ultrasound-guided paravertebral block

Arm

Intervention/Treatment

Experimental: Erector spinae plane block

Ultrasound-guided erector spinae plane block

Procedure: Erector spinae plane block

Ultrasound-guided erector spinae plane block

Experimental: Paravertebral

Ultrasound-guided thoracic paravertebral block

Procedure: Paravertebral block

Ultrasound-guided paravertebral block

Outcome Measures

Primary Outcome Measures

Total consumption of paracetamol [The first 24 hours postoperatively]
Time to first rescue analgesia [The first 24 hours postoperatively]

Secondary Outcome Measures

The concentration of sevoflurane in percent [Through the surgery, an average of 2 hours]
Systolic, diastolic, and mean blood pressure during surgery in mmHg [Through the surgery, an average of 2 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut University	Assiut		Egypt	71515

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hany Mostafa Esmaeil Osman, Principal Investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT05589649

Other Study ID Numbers:

ESP versus Paravertebral

First Posted:

Oct 21, 2022

Last Update Posted:

Oct 28, 2022

Last Verified:

Oct 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hany Mostafa Esmaeil Osman, Principal Investigator, Assiut University

paravertebral block

Erector spinae plane block

Percutaneous nephrolithotomy

pediatric

Additional relevant MeSH terms:

Kidney Calculi

Nephrolithiasis

Study Results

No Results Posted as of Oct 28, 2022