Renal StoneNCT05589649
Erector Spinae Versus Paravertebral in Pediatric PCNL
A study testing Erector spinae plane block and Paravertebral block in people with Renal Stone and Percutaneous, run by Assiut University at 1 site in Egypt.
Trial summary
To compare the efficacy of ultrasound-guided erector spinae plane block versus ultrasound-guided paravertebral 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
- Renal Stone, Percutaneous, Nephrolithotomy
- What is being tested?
- Erector spinae plane block and Paravertebral block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Oct 2022to 27 Dec 2023
- 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.
About this study
Official title: Ultrasound-guided Erector Spinae Plane Block Versus Ultrasound-guided Thoracic Paravertebral Block in Pediatric Patients Undergoing Percutaneous Nephrolithotomy
To compare the efficacy of ultrasound-guided erector spinae plane block versus ultrasound-guided paravertebral 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.
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.
- Conditions
- Renal Stone, Percutaneous, Nephrolithotomy
- Being tested
- Erector spinae plane block, Paravertebral block
- Keywords
- paravertebral block, Erector spinae plane block, Percutaneous nephrolithotomy, pediatric
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane blockProcedure or surgery
Ultrasound-guided erector spinae plane block
Paravertebral blockProcedure or surgery
Ultrasound-guided paravertebral block
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane block | Experimental | Ultrasound-guided erector spinae plane block Receives: Procedure: Erector spinae plane block |
| Paravertebral | Experimental | Ultrasound-guided thoracic paravertebral block Receives: Procedure: Paravertebral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total consumption of nalbuphine
Measured: The first 24 hours postoperatively
Time to first rescue analgesia
Measured: The first 24 hours postoperatively
Secondary outcomes (2)
The concentration of sevoflurane in percent
Measured: Through the surgery, an average of 2 hours
Systolic, diastolic, and mean blood pressure during surgery in mmHg
Measured: Through the surgery, an average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start26 Oct 2022
- Primary completion27 Sep 2023
- Study completion27 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal StoneStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
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
- NCT05589649
- Sponsor's protocol ID
- ESP versus Paravertebral
- Status last verified
- Jan 2024
- First submitted
- 18 Oct 2022
- Last updated
- 10 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nabil F, Mandour AM, Abdelgawad AM, Tamer DM, Shahat AA, Anwar M, Osman HM. Erector spinae plane block versus thoracic paravertebral block in pediatric patients undergoing percutaneous nephrolithotomy: a prospective randomized clinical trial. Braz J Anesthesiol. 2026 May-Jun;76(3):844735. doi: 10.1016/j.bjane.2026.844735. Epub 2026 Feb 4.
PubMed 41651163
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Erector Spinae Plane Block Versus Ultrasound-guided Thoracic Paravertebral Block in Pediatric Patients Undergoing Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT05589649
- Acronym / sponsor ID
- ESP versus Paravertebral
- Conditions
- Renal Stone, Percutaneous, Nephrolithotomy
- Keywords
- paravertebral block, Erector spinae plane block, Percutaneous nephrolithotomy, pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 27 Dec 2023 (actual)
- First posted
- 21 Oct 2022 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane block | Experimental | Procedure: Erector spinae plane blockUltrasound-guided erector spinae plane block |
| Paravertebral | Experimental | Procedure: Paravertebral blockUltrasound-guided thoracic paravertebral 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 |
|---|---|---|
| Erector spinae plane blockUltrasound-guided erector spinae plane block | Procedure or surgery | Erector spinae plane block |
| Paravertebral blockUltrasound-guided paravertebral block | Procedure or surgery | Paravertebral |
Primary outcome
Total consumption of nalbuphine
Time frame: The first 24 hours postoperatively
Time to first rescue analgesia
Time frame: The first 24 hours postoperatively
2 secondary outcomes
The concentration of sevoflurane in percent
Time frame: Through the surgery, an average of 2 hours
Systolic, diastolic, and mean blood pressure during surgery in mmHg
Time frame: Through the surgery, an average of 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Derived from this study: PubMed 41651163Nabil F, Mandour AM, Abdelgawad AM, Tamer DM, Shahat AA, Anwar M, Osman HM. Erector spinae plane block versus thoracic paravertebral block in pediatric patients undergoing percutaneous nephrolithotomy: a prospective randomized clinical trial. Braz J Anesthesiol. 2026 May-Jun;76(3):844735. doi: 10.1016/j.bjane.2026.844735. Epub 2026 Feb 4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae plane block and Paravertebral block in people with Renal Stone and Percutaneous, 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: finished, as of the sponsor's last update on 10 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total consumption of nalbuphine (time frame: The first 24 hours postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05589649, which also lists 1 linked publication.
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 10 Jan 2024.