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

NCT06462573 | Not Yet Recruiting Early Phase 1

• 1 other identifier: Eswl
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Comparison between local and systemic analgesia

  Pain score during the session using visual analogue scale

  Baseline

Secondary Outcomes (1)

• Comparison between local and systemic analgesia

  Baseline

Study Arms (2)

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.

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.

Drug: general anaethesia

Interventions

locally infilterating anaethesia like lidocaine 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.

Also known as: Group I (study group)

Group I (study group)

general anaethesia 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.

Also known as: Group II (control group)

Group II (control group)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Manzoor H, Leslie SW, Saikali SW. Extracorporeal Shockwave Lithotripsy. 2024 Oct 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK560887/

  PMID: 32809722 BACKGROUND

• Laksita 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.

  PMID: 35118950 BACKGROUND

Related Links

• personal email

MeSH Terms

Conditions

Ureterolithiasis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Salah El-Din Shaker Abdel Hafez

  professor

  STUDY DIRECTOR

• Nasreldin Abdelaal

  assistant professor

  STUDY DIRECTOR

Central Study Contacts

Hosam salah AbdelRaheem, Resident

CONTACT

01024591522; hossalah111@gmail.com

Amr Esam Saad Mohamed Darwish Darwish, Staff member

CONTACT

01015817851; amrdarwish@edu.eg

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 17, 2024

Record last verified: 2024-06