Extra-Corporeal Shock Wave Lithotripsy for Renal and Upper Ureteral Stones in Adults Under Locally Infiltrate d Anaesthetics ; a Clinical Randomized Controlled Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2026-09-01

Brief Summary

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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

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Detailed Description

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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

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Stone Ureter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Group I (study group)

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.

Group Type EXPERIMENTAL

locally infilterating anaethesia like lidocaine

Intervention Type DRUG

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)

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.

Group Type EXPERIMENTAL

general anaethesia

Intervention Type DRUG

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.

Interventions

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locally infilterating anaethesia like lidocaine

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.

Intervention Type DRUG

general anaethesia

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.

Intervention Type DRUG

Other Intervention Names

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Group I (study group) Group II (control group)

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes