Quadratus Lumborum Block Versus Erector Spinae Plane Block in Extracorporeal Shock Wave Lithotripsy(ESWL)

Not Applicable

Completed

• Conditions: Lithiasis; Pain
• Interventions: Procedure: Erector spinae plane block; Procedure: Quadratus lumborum block type III

• Registration Number: NCT05937256
• Lead Sponsor: South Valley University

Brief Summary

This study is designed to compare analgesic effect of both the ultrasound (US)-guided QLB and ESPB blocks during ESWL and their effect on stone fragmentation.

Detailed Description

Urinary tract calculi, one of the most common benign urological diseases, is seen in 12% of patients and has a recurrence rate of approximately 50%.

Management of renal calculi is known to be affected by many factors, specially tolerance of pain during ESWL and how it is controlled.

Pain experienced during ESWL is thought to occur when shock waves from the lithotripter reach superficial structures such as skin and also deeper structures such as the ribs, nerves and the kidney capsule. There are three main factors that contribute to the propagation of pain at these structures: shock wave (SW) pressure, distribution, and focal area size .

Conventionally, pain during ESWL is managed by basic analgesics such as NSAIDs, which can also aid in stone clearance. Other methods of analgesia also have been studied and tested.

Quadratus lumborum block (QLB) was first described by Blanco in 2007, it blocks T7-L1 nerve fibres in most of the cases. Studies have reported its use in the management of postoperative pain after hip surgeries.

"Erector Spinae Plane Block" (ESPB) is another such block, that is increasingly tried for the management of postoperative pain for breast surgery, thoracic surgery, and also upper abdominal surgeries. ESPB when given at the lumbar region gives blockade from C7-T2 to L2-L3.

Study Timeline

• Study First Submitted: 2023-05-28
• Study First Submitted QC: 2023-06-30
• Study First Posted: 2023-07-10
• Study Start: 2023-12-01
• Primary Completion: 2024-09-01
• Study Completion: 2024-12-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-16
• Last Update Posted: 2025-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Informed written consent obtained
• Age 18-60
• Both sex
• American Society of Anesthesiologists(ASA) physical status: I, II
• Stone pelvis less than 2.5 cm
• Indicated for ESWL

Exclusion Criteria

• refusal of participation by parents or caregivers.
• ASA physical status: > II
• Stone pelvis >2.5 cm
• Chronic pain
• On chronic NSAID or opioid
• Substance addict
• Known local anesthetic drug sensitivity.
• Preexisting infection at block site
• Coagulopathy or anticoagulation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group E	Erector spinae plane block	(n=30) will receive unilateral erector spinae plane block
Group Q	Quadratus lumborum block type III	(n=30) will receive unilateral quadratus lumborum block type III

Primary Outcome Measures

Name	Time	Method
Analgesic Effect: cumulative opioid dose	At 30 minutes	Comparing analgesic Effect of both QLB and ESPB by calculating the total opioid consumption over the total duration of session (approximately 30 minutes)

Secondary Outcome Measures

Name	Time	Method
Block failure rate	Immediately After 20 minutes of intervention	the block will be considered a failed block if the sensory block level of T7-L1 is not achieved after assessment with pinprick test.
Stone fragmentation: clearance rate	one week after ESWL session	Determining if stone fragmentation considered satisfactory or not, by Follow up kidney, ureter and bladder x-ray (KUB) and Ultrasound.
Adverse effects	immediately after 20 minutes of intervention	The incidence of adverse effects local (anesthetic toxic reactions, bleeding, or hematoma at the puncture position; failure of block).
The regional block time	procedure (At the end of intervention)	defined as the time taken from the start of the ultrasound scan to the completion of the local anesthetic injection.
Feasibility of visualisation	procedure (At the end of intervention)	The ultrasound images will be evaluated with a 4-point method(10) : 0 points, unable to display; 1 point, the anatomical structure and injection target position are not clear, and the puncture needle is partially developed; 2 points, the anatomical structure, and injection target position are clear, but the puncture needle tip is poorly developed, and local anesthetic diffusion is limited; 3 points, typical anatomical structure, and injection target position, the puncture needle tip can be accurately identified, and local anesthetic diffusion is complete. Images with ≥2 points meant that local anesthetics could be injected.
Stone fragmentation: shockwave energy	at 30 minutes	the level of energy will increase gradually, with shock waves between 3,500 and 5,000 in the 2-4 kilovolt (kV) energy range. Fluoroscopy will be used to check the stone and confirm fragmentation. Then maximum and mean energy of shock that is used will be calculated at the end of session approximately 30 min
Patient satisfaction	At 30 minutes	patient satisfaction will be recorded after the procedure using a five-point scale, where 1 is unsatisfied and 5 completely satisfied. At the end of session approximately 30 minutes

Trial Locations

Locations (1)

South Valley University; 🇪🇬 Qinā, Qena, Egypt