Renal StoneNCT07067996
Erector Spinae Plane Block for Analgesia During ESWL
A study testing erector spinae plane block and Nalbuphine in people with Renal Stone, run by Sohag University at 1 site in Egypt.
Trial summary
this study aims to compare between efficacy of erector spinae plane block and conventional multimodal analgesia in Extracorporeal shock wave lithotripsy Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Renal Stone
- What is being tested?
- erector spinae plane block and Nalbuphine
- 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
- 13 Jun 2025to 15 Feb 2026
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult Patients undergoing ESWL with 2-3 cm renal stones
- patients between the ages of 21 and 60,
- both sexes,
- BMI ≥18≤30 kg/m²
- Able to give informed consent.
- Patients older than 18 years with American Society of Anesthesiologists Physical Status I or II and
Who cannot join
- Coagulopathy or on anticoagulants
- Infection at the ESPB injection site
- BMI ≥30 kg/m²
- Patient refusal.
- patients with advanced respiratory, renal, hepatic, neurological, or psychiatric disease, pregnant or nursing women.
- patients with a history of allergies to any study drugs
Trial locations and contacts
1 site in 1 country.
About this study
this study aims to compare between efficacy of erector spinae plane block and conventional multimodal analgesia in Extracorporeal shock wave lithotripsy
- Conditions
- Renal Stone
- Being tested
- erector spinae plane block, Nalbuphine
- 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
erector spinae plane block will be given as intraoperive analgesia for patients undergoing Extracorporeal shock wave lithotripsy
NalbuphineDrug
Nalbuphine will be given as intraopertive analgesia for patients undergoing Extracorporeal shock wave lithotripsy
| Study group | Role | What they receive |
|---|---|---|
| group A : will receive Erector Spinae Plane Block in the prone position after URS. | Active comparator | * Patients in the block group (Group A)will receive the ESPB in the prone position after URS. ESPB needle insertion sites will be tolerated to the location of the stone, between T7-T10 vertebra levels. With these adjustments, Following the marking of the thoracic vertebrae levels with a marker pen,
* The intervention will be initiated when the transverse processes and costotransverse joints on the relevant level will be distinguished using a high frequency(10-15 MHZ) linear ultrasound probe. The needle will be inserted at a 30° angle to the skin in an in-plane and craniocaudal fashion
* Proper placement will be confirmed with ultrasonography and then 20 mL of 0.25% bupivacaine solution\&5 ml lidocaine 1% will be administered through the needle for intraoperative and postoperative anaglesia. Receives: Procedure: erector spinae plane block |
| group B : will receive nalbuphine | Active comparator | •(Group B) patients will receive opioids ,nalbuphine( ,1 )mg/kg over 10 minutes then repeat the dose if needed \&monitoring patients for respiratory depression Receives: Drug: Nalbuphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
This study aims to evaluate the efficacy of Erector Spinae Plane Block analgesia for patients undergoing ESWL &compare between it and conventional multimodal Analgesia .
postoperative pain by visual analog score from 0 to 10 (where 0 indicates no pain and 10 the worst possible pain
Measured: 6 hours postopertive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start13 Jun 2025
- Primary completion15 Feb 2026
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Abdelsabor, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067996
- Sponsor's protocol ID
- Soh-Med--25-6-8MS
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Karaaslan M, Olcucuoglu E, Kurtbeyoglu S, Tonyali S, Yilmaz M, Odabas O. Erector spinae plane block prior to extracorporeal shock wave lithotripsy decreases fluoroscopy time and promise a comfortable procedure for renal stones: A prospective randomized study. Actas Urol Esp (Engl Ed). 2023 Nov;47(9):566-572. doi: 10.1016/j.acuroe.2023.04.001. Epub 2023 Apr 20. English, Spanish.
PubMed 37084807Yayik AM, Ahiskalioglu A, Erguney OD, Oral Ahiskalioglu E, Alici H, Demirdogen SO, Adanur S. Analgesic efficacy of ultrasound-guided quadratus lumborum block during extracorporeal shock wave lithotripsy. Agri. 2020 Jan;32(1):44-47. doi: 10.5505/agri.2017.54036.
PubMed 32030700Alhashemi JA, Kaki AM. Dexmedetomidine in combination with morphine PCA provides superior analgesia for shockwave lithotripsy. Can J Anaesth. 2004 Apr;51(4):342-7. doi: 10.1007/BF03018237.
PubMed 15064262
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block for Analgesia During ESWL
- ClinicalTrials.gov ID
- NCT07067996
- Acronym / sponsor ID
- Soh-Med--25-6-8MS
- Conditions
- Renal Stone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 16 Jul 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.
this study aims to compare between efficacy of erector spinae plane block and conventional multimodal analgesia in Extracorporeal shock wave lithotripsy
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A : will receive Erector Spinae Plane Block in the prone position after URS. | Active comparator | Procedure: erector spinae plane block* Patients in the block group (Group A)will receive the ESPB in the prone position after URS. ESPB needle insertion sites will be tolerated to the location of the stone, between T7-T10 vertebra levels. With these adjustments, Following the marking of the thoracic vertebrae levels with a marker pen, * The intervention will be initiated when the transverse processes and costotransverse joints on the relevant level will be distinguished using a high frequency(10-15 MHZ) linear ultrasound probe. The needle will be inserted at a 30° angle to the skin in an in-plane and craniocaudal fashion * Proper placement will be confirmed with ultrasonography and then 20 mL of 0.25% bupivacaine solution\&5 ml lidocaine 1% will be administered through the needle for intraoperative and postoperative anaglesia. |
| group B : will receive nalbuphine | Active comparator | Drug: Nalbuphine•(Group B) patients will receive opioids ,nalbuphine( ,1 )mg/kg over 10 minutes then repeat the dose if needed \&monitoring patients for respiratory depression |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adult Patients undergoing ESWL with 2-3 cm renal stones
- patients between the ages of 21 and 60,
- both sexes,
- BMI ≥18≤30 kg/m²
- Able to give informed consent.
Key exclusion criteria (6 listed)
- Coagulopathy or on anticoagulants
- Infection at the ESPB injection site
- BMI ≥30 kg/m²
- Patient refusal.
- patients with advanced respiratory, renal, hepatic, neurological, or psychiatric disease, pregnant or nursing women.
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 blockerector spinae plane block will be given as intraoperive analgesia for patients undergoing Extracorporeal shock wave lithotripsy | Procedure or surgery | group A : will receive Erector Spinae Plane Block in the prone position after URS. |
| NalbuphineNalbuphine will be given as intraopertive analgesia for patients undergoing Extracorporeal shock wave lithotripsy | Drug | group B : will receive nalbuphine |
Primary outcome
This study aims to evaluate the efficacy of Erector Spinae Plane Block analgesia for patients undergoing ESWL &compare between it and conventional multimodal Analgesia .
Time frame: 6 hours postopertive
postoperative pain by visual analog score from 0 to 10 (where 0 indicates no pain and 10 the worst possible pain
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 28 Jul 2026.
- Results publication: PubMed 37084807Karaaslan M, Olcucuoglu E, Kurtbeyoglu S, Tonyali S, Yilmaz M, Odabas O. Erector spinae plane block prior to extracorporeal shock wave lithotripsy decreases fluoroscopy time and promise a comfortable procedure for renal stones: A prospective randomized study. Actas Urol Esp (Engl Ed). 2023 Nov;47(9):566-572. doi: 10.1016/j.acuroe.2023.04.001. Epub 2023 Apr 20. English, Spanish.
- Results publication: PubMed 32030700Yayik AM, Ahiskalioglu A, Erguney OD, Oral Ahiskalioglu E, Alici H, Demirdogen SO, Adanur S. Analgesic efficacy of ultrasound-guided quadratus lumborum block during extracorporeal shock wave lithotripsy. Agri. 2020 Jan;32(1):44-47. doi: 10.5505/agri.2017.54036.
- Results publication: PubMed 15064262Alhashemi JA, Kaki AM. Dexmedetomidine in combination with morphine PCA provides superior analgesia for shockwave lithotripsy. Can J Anaesth. 2004 Apr;51(4):342-7. doi: 10.1007/BF03018237.
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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 Nalbuphine in people with Renal Stone, run by Sohag 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 6 inclusion and 6 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 28 Jul 2026. 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?
This study aims to evaluate the efficacy of Erector Spinae Plane Block analgesia for patients undergoing ESWL &compare between it and conventional multimodal Analgesia . (time frame: 6 hours postopertive). 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 NCT07067996, which also lists 3 linked publications.
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 28 Jul 2026.