Stone UreterEarly Phase 1NCT06462573
Extra-Corporeal Shock Wave Lithotripsy for Renal and Upper Ureteral Stones in Adults Under Locally Infiltrate d Anaesthetics ; a Clinical Randomized Controlled Study
A Early Phase 1 study testing locally infilterating anaethesia like lidocaine and general anaethesia in people with Stone Ureter, run by Assiut University.
Trial summary
There are many treatment modalities available for managing renal and upper ureteric stones. They range from completely non-invasive outpatient procedures to invasive procedures requiring hospital admission and increased risks of complications. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stone Ureter
- What is being tested?
- locally infilterating anaethesia like lidocaine and general anaethesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Sep 2026
- Phase
- Early Phase 1
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older whether males or females with renal or upper ureteric stone(s) candidate for ESWL therapy 2. Renal stones should be between 1- 2 cm and upper ureteric stones should be less than 15 mm
Who cannot join
- 1.. Patients refusing to participate in the study or patients not compliant with follow up 2. Renal stones in ectopic kidneys 3. Radiolucent upper ureteric stones 4. Patients with myo-skeletal deformities e.g. kyphoscoliosis
Trial locations and contacts
No sites are listed yet.
About this study
There are many treatment modalities available for managing renal and upper ureteric stones. They range from completely non-invasive outpatient procedures to invasive procedures requiring hospital admission and increased risks of complications. Extracorporeal shockwave lithotripsy (ESWL) is a truly non-invasive procedure as opposed to other surgical treatments used, such as retrograde intrarenal surgery and percutaneous nephrolithotomy (1).
The choice between shockwave lithotripsy (SWL) and other treatment modalities depends on several factors, including stone site, stone burden, stone CT density, etc. Another compounding factor in choosing the treatment modality is patient preference and expectation (1).
Read more
Extracorporeal Shock Wave Lithotripsy is one of the treatment options for patients with renal and ureteral calculi. Even though the procedure is less invasive compared to others. Pain caused by the procedure is a major concern. Several studies recommended the use of either local or systemic analgesia with varying results (2).
As a truly non-invasive treatment option, ESWL has been widely used for treating renal, as well as ureteric, stones with satisfactory efficacy and minimal morbidity. However, the pain caused by ESWL is a major limitation of its efficacy, in addition to the associated patient dissatisfaction and negative experience that may result in the patient refraining from further sessions.
The relationship between pain and ESWL efficacy can be explained by multiple facts: firstly, the pain leads to inability to increase the energy delivered by the shockwaves to optimum levels; secondly, the pain usually leads to significant movement of the patient, as well as excessive respiratory movements, both of which move the stone away from the focus of shockwaves; lastly, the pain may be severe that the session is discontinued before delivery of effective number of shockwaves
Read the detailed description
There are many treatment modalities available for managing renal and upper ureteric stones. They range from completely non-invasive outpatient procedures to invasive procedures requiring hospital admission and increased risks of complications. Extracorporeal shockwave lithotripsy (ESWL) is a truly non-invasive procedure as opposed to other surgical treatments used, such as retrograde intrarenal surgery and percutaneous nephrolithotomy (1).
The choice between shockwave lithotripsy (SWL) and other treatment modalities depends on several factors, including stone site, stone burden, stone CT density, etc. Another compounding factor in choosing the treatment modality is patient preference and expectation (1).
Extracorporeal Shock Wave Lithotripsy is one of the treatment options for patients with renal and ureteral calculi. Even though the procedure is less invasive compared to others. Pain caused by the procedure is a major concern. Several studies recommended the use of either local or systemic analgesia with varying results (2).
As a truly non-invasive treatment option, ESWL has been widely used for treating renal, as well as ureteric, stones with satisfactory efficacy and minimal morbidity. However, the pain caused by ESWL is a major limitation of its efficacy, in addition to the associated patient dissatisfaction and negative experience that may result in the patient refraining from further sessions.
The relationship between pain and ESWL efficacy can be explained by multiple facts: firstly, the pain leads to inability to increase the energy delivered by the shockwaves to optimum levels; secondly, the pain usually leads to significant movement of the patient, as well as excessive respiratory movements, both of which move the stone away from the focus of shockwaves; lastly, the pain may be severe that the session is discontinued before delivery of effective number of shockwaves
- Conditions
- Stone Ureter
- Being tested
- locally infilterating anaethesia like lidocaine, general anaethesia
- Medical subject headings
- Ureterolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
locally infilterating anaethesia like lidocaineDrug
Also called Group I (study group)
which patients will undergo ESWL under locally infiltrated anaesthetic. Using ultrasound guidance, the quadratus lumborum muscle will be identified. Then a mixture of 0.5 % bupivacaine (10 ml) and 2 % lidocaine (10 ml) will be injected into the muscle as a single shot 20 minutes before the procedure.
general anaethesiaDrug
Also called Group II (control group)
which patients will undergo ESWL under systemic analgesia. The latter will be achieved using one gram of paracetamol IV infusion at the beginning of the procedure.
In case of unsatisfactory pain control in either group, systemic analgesia using IV Ketorolac injection will be used on demand or the required dose will be recorded at the end of the session.
| Study group | Role | What they receive |
|---|---|---|
| Group I (study group) | Experimental | in which patients will undergo ESWL under locally infiltrated anaesthetic. Using ultrasound guidance, the quadratus lumborum muscle will be identified. Then a mixture of 0.5 % bupivacaine (10 ml) and 2 % lidocaine (10 ml) will be injected into the muscle as a single shot 20 minutes before the procedure. Receives: Drug: locally infilterating anaethesia like lidocaine |
| Group II (control group) | Experimental | in which patients will undergo ESWL under systemic analgesia. The latter will be achieved using one gram of paracetamol IV infusion at the beginning of the procedure.
In case of unsatisfactory pain control in either group, systemic analgesia using IV Ketorolac injection will be used on demand or the required dose will be recorded at the end of the session. Receives: Drug: general anaethesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between local and systemic analgesia
Pain score during the session using visual analogue scale
Measured: Baseline
Secondary outcomes (1)
Comparison between local and systemic analgesia
- Two-month stone free rate (SFR)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stone UreterStudies 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hosam salah abd elrahim, Assiut University
- Investigators
- Salah El-Din Shaker Abdel Hafez, Study director, professorNasreldin Abdelaal, Study director, assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462573
- Sponsor's protocol ID
- Eswl
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Manzoor H, Leslie SW, Saikali SW. Extracorporeal Shockwave Lithotripsy. 2024 Oct 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK560887/
PubMed 32809722Laksita TB, Soebadi MA, Wirjopranoto S, Hidayatullah F, Kloping YP, Rizaldi F. Local anesthetics versus systemic analgesics for reducing pain during Extracorporeal Shock Wave Lithotripsy (ESWL): A systematic review and meta-analysis. Turk J Urol. 2021 Jul;47(4):270-278. doi: 10.5152/tju.2021.21143.
PubMed 35118950
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extra-Corporeal Shock Wave Lithotripsy for Renal and Upper Ureteral Stones in Adults Under Locally Infiltrate d Anaesthetics ; a Clinical Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06462573
- Acronym / sponsor ID
- Eswl
- Conditions
- Stone Ureter
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 17 Jun 2024 (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.
There are many treatment modalities available for managing renal and upper ureteric stones. They range from completely non-invasive outpatient procedures to invasive procedures requiring hospital admission and increased risks of complications. Extracorporeal shockwave lithotripsy (ESWL) is a truly non-invasive procedure as opposed to other surgical treatments used, such as retrograde intrarenal surgery and percutaneous nephrolithotomy (1).
The choice between shockwave lithotripsy (SWL) and other treatment modalities depends on several factors, including stone site, stone burden, stone CT density, etc. Another compounding factor in choosing the treatment modality is patient preference and expectation (1).
Extracorporeal Shock Wave Lithotripsy is one of the treatment options for patients with renal and ureteral calculi. Even though the procedure is less invasive compared to others. Pain caused by the procedure is a major concern. Several studies recommended the use of either local or systemic analgesia with varying results (2).
As a truly non-invasive treatment option, ESWL has been widely used for treating renal, as well as ureteric, stones with satisfactory efficacy and minimal morbidity. However, the pain caused by ESWL is a major limitation of its efficacy, in addition to the associated patient dissatisfaction and negative experience that may result in the patient refraining from further sessions.
The relationship between pain and ESWL efficacy can be explained by multiple facts: firstly, the pain leads to inability to increase the energy delivered by the shockwaves to optimum levels; secondly, the pain usually leads to significant movement of the patient, as well as excessive respiratory movements, both of which move the stone away from the focus of shockwaves; lastly, the pain may be severe that the session is discontinued before delivery of effective number of shockwaves
Detailed description
There are many treatment modalities available for managing renal and upper ureteric stones. They range from completely non-invasive outpatient procedures to invasive procedures requiring hospital admission and increased risks of complications. Extracorporeal shockwave lithotripsy (ESWL) is a truly non-invasive procedure as opposed to other surgical treatments used, such as retrograde intrarenal surgery and percutaneous nephrolithotomy (1).
The choice between shockwave lithotripsy (SWL) and other treatment modalities depends on several factors, including stone site, stone burden, stone CT density, etc. Another compounding factor in choosing the treatment modality is patient preference and expectation (1).
Extracorporeal Shock Wave Lithotripsy is one of the treatment options for patients with renal and ureteral calculi. Even though the procedure is less invasive compared to others. Pain caused by the procedure is a major concern. Several studies recommended the use of either local or systemic analgesia with varying results (2).
As a truly non-invasive treatment option, ESWL has been widely used for treating renal, as well as ureteric, stones with satisfactory efficacy and minimal morbidity. However, the pain caused by ESWL is a major limitation of its efficacy, in addition to the associated patient dissatisfaction and negative experience that may result in the patient refraining from further sessions.
The relationship between pain and ESWL efficacy can be explained by multiple facts: firstly, the pain leads to inability to increase the energy delivered by the shockwaves to optimum levels; secondly, the pain usually leads to significant movement of the patient, as well as excessive respiratory movements, both of which move the stone away from the focus of shockwaves; lastly, the pain may be severe that the session is discontinued before delivery of effective number of shockwaves
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (study group) | Experimental | Drug: locally infilterating anaethesia like lidocainein which patients will undergo ESWL under locally infiltrated anaesthetic. Using ultrasound guidance, the quadratus lumborum muscle will be identified. Then a mixture of 0.5 % bupivacaine (10 ml) and 2 % lidocaine (10 ml) will be injected into the muscle as a single shot 20 minutes before the procedure. |
| Group II (control group) | Experimental | Drug: general anaethesiain which patients will undergo ESWL under systemic analgesia. The latter will be achieved using one gram of paracetamol IV infusion at the beginning of the procedure. In case of unsatisfactory pain control in either group, systemic analgesia using IV Ketorolac injection will be used on demand or the required dose will be recorded at the end of the session. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 years or older whether males or females with renal or upper ureteric stone(s) candidate for ESWL therapy 2. Renal stones should be between 1- 2 cm and upper ureteric stones should be less than 15 mm
Key exclusion criteria (1 listed)
- 1.. Patients refusing to participate in the study or patients not compliant with follow up 2. Renal stones in ectopic kidneys 3. Radiolucent upper ureteric stones 4. Patients with myo-skeletal deformities e.g. kyphoscoliosis
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 |
|---|---|---|
| locally infilterating anaethesia like lidocaineAlso: Group I (study group)which patients will undergo ESWL under locally infiltrated anaesthetic. Using ultrasound guidance, the quadratus lumborum muscle will be identified. Then a mixture of 0.5 % bupivacaine (10 ml) and 2 % lidocaine (10 ml) will be injected into the muscle as a single shot 20 minutes before the procedure. | Drug | Group I (study group) |
| general anaethesiaAlso: Group II (control group)which patients will undergo ESWL under systemic analgesia. The latter will be achieved using one gram of paracetamol IV infusion at the beginning of the procedure. In case of unsatisfactory pain control in either group, systemic analgesia using IV Ketorolac injection will be used on demand or the required dose will be recorded at the end of the session. | Drug | Group II (control group) |
Primary outcome
Comparison between local and systemic analgesia
Time frame: Baseline
Pain score during the session using visual analogue scale
1 secondary outcome
Comparison between local and systemic analgesia
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Background: PubMed 32809722Manzoor H, Leslie SW, Saikali SW. Extracorporeal Shockwave Lithotripsy. 2024 Oct 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK560887/
- Background: PubMed 35118950Laksita TB, Soebadi MA, Wirjopranoto S, Hidayatullah F, Kloping YP, Rizaldi F. Local anesthetics versus systemic analgesics for reducing pain during Extracorporeal Shock Wave Lithotripsy (ESWL): A systematic review and meta-analysis. Turk J Urol. 2021 Jul;47(4):270-278. doi: 10.5152/tju.2021.21143.
- personal emailLink provided by the sponsor.
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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.
Salah El-Din Shaker Abdel Hafez study director
professor
Nasreldin Abdelaal study director
assistant professor
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing locally infilterating anaethesia like lidocaine and general anaethesia in people with Stone Ureter, run by Assiut 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: status not confirmed, as of the sponsor's last update on 17 Jun 2024. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hosam salah AbdelRaheem, Resident (01024591522, hossalah111@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between local and systemic analgesia (time frame: Baseline). 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 NCT06462573, which also lists 2 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 17 Jun 2024.