Back to resultsErector Spinae Versus Paravertebral in Pediatric PCNL
Primary Purpose
Renal Stone, Percutaneous, Nephrolithotomy
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Erector spinae plane block
Paravertebral block
Sponsored by
About this trial
This is an interventional treatment trial for Renal Stone focused on measuring paravertebral block, Erector spinae plane block, Percutaneous nephrolithotomy, pediatric
Eligibility Criteria
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
Sites / Locations
- Assiut UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Erector spinae plane block
Paravertebral
Arm Description
Ultrasound-guided erector spinae plane block
Ultrasound-guided thoracic paravertebral block
Outcomes
Primary Outcome Measures
Total consumption of paracetamol
Time to first rescue analgesia
Secondary Outcome Measures
The concentration of sevoflurane in percent
Systolic, diastolic, and mean blood pressure during surgery in mmHg
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05589649
Brief Title
Erector Spinae Versus Paravertebral in Pediatric PCNL
Official Title
Ultrasound-guided Erector Spinae Plane Block Versus Ultrasound-guided Thoracic Paravertebral Block in Pediatric Patients Undergoing Percutaneous Nephrolithotomy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2022 (Actual)
Primary Completion Date
September 27, 2023 (Anticipated)
Study Completion Date
October 27, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Stone, Percutaneous, Nephrolithotomy
Keywords
paravertebral block, Erector spinae plane block, Percutaneous nephrolithotomy, pediatric
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Erector spinae plane block
Arm Type
Experimental
Arm Description
Ultrasound-guided erector spinae plane block
Arm Title
Paravertebral
Arm Type
Experimental
Arm Description
Ultrasound-guided thoracic paravertebral block
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane block
Intervention Description
Ultrasound-guided erector spinae plane block
Intervention Type
Procedure
Intervention Name(s)
Paravertebral block
Intervention Description
Ultrasound-guided paravertebral block
Primary Outcome Measure Information:
Title
Total consumption of paracetamol
Time Frame
The first 24 hours postoperatively
Title
Time to first rescue analgesia
Time Frame
The first 24 hours postoperatively
Secondary Outcome Measure Information:
Title
The concentration of sevoflurane in percent
Time Frame
Through the surgery, an average of 2 hours
Title
Systolic, diastolic, and mean blood pressure during surgery in mmHg
Time Frame
Through the surgery, an average of 2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hany M. Osman, M.D.
Phone
+201002414591
Email
hanymeo@aun.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Anwar, M.D.
Phone
+201002414590
Email
dr.mohamedanwar@aun.edu.eg
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hany M. Osman, M.D.
Phone
+201002414591
Email
hanymeo@aun.edu.eg
First Name & Middle Initial & Last Name & Degree
Mohamed Anwar
Phone
+201002414590
Email
dr.mohamedanwar@aun.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Erector Spinae Versus Paravertebral in Pediatric PCNL
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