Percutaneous Nephrolithotomy (PCNL)NCT06935006
Erector Spinae Block vs Conventional Analgesia for Postoperative Analgesia in PCNL
A study testing Sonographic guided Erector spinae plane block and Intravenous opioid in people with Percutaneous Nephrolithotomy (PCNL), run by Sohag University.
Trial summary
50 adult patients scheduled for percutaneous nephrolithotomy in Sohag university hospitals will be devided in two groups one of them will receive Sonographic guided erector spinae plane block using 20 ml volume of bupivacaine 0.25 percent and the other will receive conventional analgesia of 0.1 mg/kg IV morphine Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Percutaneous Nephrolithotomy (PCNL)
- What is being tested?
- Sonographic guided Erector spinae plane block and Intravenous opioid
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA 1 to ASA 2 18 to 60 years
Who cannot join
- patient refusal Significant neurological , psychiatric or neuromascular disease Drug abuse Pregnant or lactating women Suspected coagulopathy Morbid obesity Known allergy to some medications Septicaemia and local infection at block site
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Fawzy Abbas, Assistant professor contact
About this study
Official title: Sonographic Guided Erector Spinae Plane Block Versus Conventional Analgesia After Percutaneous Nephrolithotomy a Comparative Randomized Study
50 adult patients scheduled for percutaneous nephrolithotomy in Sohag university hospitals will be devided in two groups one of them will receive Sonographic guided erector spinae plane block using 20 ml volume of bupivacaine 0.25 percent and the other will receive conventional analgesia of 0.1 mg/kg IV morphine
- Conditions
- Percutaneous Nephrolithotomy (PCNL)
- Being tested
- Sonographic guided Erector spinae plane block, Intravenous opioid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonographic guided Erector spinae plane blockProcedure or surgery
Ultrasound guided plane block using 20 ml of 0.25% bupivacaine at the level of transverse process of T8
Intravenous opioidDrug
0.1 mg/kg morphine intravenous pre operative
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane block group | Active comparator | Not described Receives: Procedure: Sonographic guided Erector spinae plane block |
| Conventional analgesia group | Active comparator | Not described Receives: Drug: Intravenous opioid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of postoperative pain
VAS score for pain measurement
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Nephrolithotomy (PCNL)Studies of the same condition, open and under way.
- More trials run by Sohag 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahmoud Azmy, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935006
- Sponsor's protocol ID
- Soh-Med-22-06-35
- Status last verified
- Apr 2025
- First submitted
- 9 Mar 2025
- Last updated
- 18 Apr 2025
- 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 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Guided Erector Spinae Plane Block Versus Conventional Analgesia After Percutaneous Nephrolithotomy a Comparative Randomized Study
- ClinicalTrials.gov ID
- NCT06935006
- Acronym / sponsor ID
- Soh-Med-22-06-35
- Conditions
- Percutaneous Nephrolithotomy (PCNL)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 18 Apr 2025 (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.
50 adult patients scheduled for percutaneous nephrolithotomy in Sohag university hospitals will be devided in two groups one of them will receive Sonographic guided erector spinae plane block using 20 ml volume of bupivacaine 0.25 percent and the other will receive conventional analgesia of 0.1 mg/kg IV morphine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane block group | Active comparator | Procedure: Sonographic guided Erector spinae plane block |
| Conventional analgesia group | Active comparator | Drug: Intravenous opioid |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA 1 to ASA 2 18 to 60 years
Key exclusion criteria (1 listed)
- patient refusal Significant neurological , psychiatric or neuromascular disease Drug abuse Pregnant or lactating women Suspected coagulopathy Morbid obesity Known allergy to some medications Septicaemia and local infection at block site
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 |
|---|---|---|
| Sonographic guided Erector spinae plane blockUltrasound guided plane block using 20 ml of 0.25% bupivacaine at the level of transverse process of T8 | Procedure or surgery | Erector spinae plane block group |
| Intravenous opioid0.1 mg/kg morphine intravenous pre operative | Drug | Conventional analgesia group |
Primary outcome
Reduction of postoperative pain
Time frame: 1 year
VAS score for pain measurement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
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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.
Fawzy Abbas, Assistant professor contact
Questions about this trial
What is this clinical trial studying?
A study testing Sonographic guided Erector spinae plane block and Intravenous opioid in people with Percutaneous Nephrolithotomy (PCNL), run by Sohag University.
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 1 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: opening soon, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Mahmoud Azmy, Assistant lecturer (01004793896, ahmedazmy19692@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of postoperative pain (time frame: 1 year). 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 18 Apr 2025.