NCT05589649

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 21, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

October 26, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2023

Completed
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

11 months

First QC Date

October 18, 2022

Last Update Submit

January 9, 2024

Conditions

Renal StonePercutaneousNephrolithotomy

Keywords

paravertebral blockErector spinae plane blockPercutaneous nephrolithotomypediatric

Outcome Measures

Primary Outcomes (2)

  • Total consumption of nalbuphine

    The first 24 hours postoperatively

  • Time to first rescue analgesia

    The first 24 hours postoperatively

Secondary Outcomes (2)

  • 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

Study Arms (2)

Erector spinae plane block

EXPERIMENTAL

Ultrasound-guided erector spinae plane block

Procedure: Erector spinae plane block

Paravertebral

EXPERIMENTAL

Ultrasound-guided thoracic paravertebral block

Procedure: Paravertebral block

Interventions

Erector spinae plane blockPROCEDURE

Ultrasound-guided erector spinae plane block

Erector spinae plane block
Paravertebral blockPROCEDURE

Ultrasound-guided paravertebral block

Paravertebral

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients undergoing percutaneous nephrolithotomy

You may not qualify if:

  • Coagulation disorders
  • Infection at the site of injection
  • Allergy to the local anesthetics used
  • Spinal cord abnormalities or neurological deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 18, 2022

First Posted

October 21, 2022

Study Start

October 26, 2022

Primary Completion

September 27, 2023

Study Completion

December 27, 2023

Last Updated

January 10, 2024

Record last verified: 2024-01

Locations

EG(1)