Kidney StonesNCT05012215
Paravertebral Versus Caudal Block in Pediatric PCNL
A study testing Paravertebral and Caudal block in people with Kidney Stones and Percutaneous Nephrolithotomy, run by Assiut University at 1 site in Egypt.
Trial summary
To compare the efficacy of Ultrasound guided thoracic paravertebral block versus ultrasound guided caudal epidural block in pediatric patients undergoing percutaneous nephrolithotomy Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Kidney Stones, Percutaneous Nephrolithotomy
- What is being tested?
- Paravertebral and Caudal block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Aug 2021to 20 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients undergoing percutaneous nephrolithotomy
Who cannot join
- Coagulation disorders
- Infection at the site of injection
- Allergy to the local anesthetics used
- Spinal cord abnormalities or neurological deficits
Trial locations and contacts
1 site in 1 country.
Fatma N. Mohamed, M.D. contact
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut, 71515
Hany M. Osman, M.D., +201002414591, hanymeo@aun.edu.eg
Fatma N. Mohamed, M.D., fatmanabil2012@gmail.com
About this study
Official title: Ultrasound Guided Thoracic Paravertebral Block Versus Ultrasound Guided Caudal Epidural Block in Pediatric Patients Undergoing Percutaneous Nephrolithotomy
To compare the efficacy of Ultrasound guided thoracic paravertebral block versus ultrasound guided caudal epidural block in pediatric patients undergoing percutaneous nephrolithotomy
Read the 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.
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.
Caudal epidural block involves placing a needle through the sacral hiatus to deliver medications into the epidural space. This approach is used widely used for surgical anesthesia and analgesia in pediatric patients.
this work aims to compare the efficacy of Ultrasound guided thoracic paravertebral block versus ultrasound guided caudal epidural block in pediatric patients undergoing percutaneous nephrolithotomy
- Conditions
- Kidney Stones, Percutaneous Nephrolithotomy
- Being tested
- Paravertebral, Caudal block
- Keywords
- paravertebral block, caudal block, Percutaneous nephrolithotomy, pediatric
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParavertebralProcedure or surgery
Ultrasound-guided paravertebral block
Caudal blockProcedure or surgery
Caudal block
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral | Experimental | Ultrasound-guided thoracic paravertebral block Receives: Procedure: Paravertebral |
| Caudal | Active comparator | Caudal block Receives: Procedure: Caudal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure during surgery in mmHg
Measured: through the surgery, an average of 2 hours
Heart rate (beats/minute)
Measured: through the surgery, an average of 2 hours
The concentration of sevoflurane in %
Measured: through the surgery, an average of 2 hours
Postoperative pain using FLACC score
Measured: up to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start19 Aug 2021
- Primary completion20 Mar 2022 (estimated)
- Study completion20 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Mostafa Esmaeil Osman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012215
- Sponsor's protocol ID
- Paravertebral Caudal PCNL
- Status last verified
- Aug 2021
- First submitted
- 6 Aug 2021
- Last updated
- 20 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Thoracic Paravertebral Block Versus Ultrasound Guided Caudal Epidural Block in Pediatric Patients Undergoing Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT05012215
- Acronym / sponsor ID
- Paravertebral Caudal PCNL
- Conditions
- Kidney Stones, Percutaneous Nephrolithotomy
- Keywords
- paravertebral block, caudal block, Percutaneous nephrolithotomy, pediatric
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 20 Mar 2022 (estimated)
- Study completion
- 20 Mar 2022 (estimated)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy of Ultrasound guided thoracic paravertebral block versus ultrasound guided caudal epidural 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.
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.
Caudal epidural block involves placing a needle through the sacral hiatus to deliver medications into the epidural space. This approach is used widely used for surgical anesthesia and analgesia in pediatric patients.
this work aims to compare the efficacy of Ultrasound guided thoracic paravertebral block versus ultrasound guided caudal epidural block in pediatric patients undergoing percutaneous nephrolithotomy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paravertebral | Experimental | Procedure: ParavertebralUltrasound-guided thoracic paravertebral block |
| Caudal | Active comparator | Procedure: Caudal blockCaudal block |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients undergoing percutaneous nephrolithotomy
Key exclusion criteria (4 listed)
- Coagulation disorders
- Infection at the site of injection
- Allergy to the local anesthetics used
- Spinal cord abnormalities or neurological deficits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParavertebralUltrasound-guided paravertebral block | Procedure or surgery | Paravertebral |
| Caudal blockCaudal block | Procedure or surgery | Caudal |
Primary outcome
Blood pressure during surgery in mmHg
Time frame: through the surgery, an average of 2 hours
Heart rate (beats/minute)
Time frame: through the surgery, an average of 2 hours
The concentration of sevoflurane in %
Time frame: through the surgery, an average of 2 hours
Postoperative pain using FLACC score
Time frame: up to 12 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma N. Mohamed, M.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paravertebral and Caudal block in people with Kidney Stones and Percutaneous Nephrolithotomy, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hany M. Osman, M.D. (+201002414591, hanymeo@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure during surgery in mmHg (time frame: through the surgery, an average of 2 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.