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

March 16, 2025 updated by: Mohamed Gaber Ahmed, South Valley University

Quadratus Lumborum Block Versus Erector Spinae Plane Block As Analgesic Alternatives During Extracorporeal Shock Wave Lithotripsy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Qena
      • Qinā, Qena, Egypt, 83523
        • South Valley University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group Q
(n=30) will receive unilateral quadratus lumborum block type III
Procedure: Quadratus lumborum block type III
Patients will be placed in lateral decubitus position with the side of the target stone facing up. After sterilization and draping of the skin, using US probe the block will be applied targeting the fascial plane between the quadratus lumborum and psoas major muscles (anterior aspect of the quadratus lumborum). After 20 min, sensory blockade will be evaluated with pinprick test, if loss of sensation is achieved at the T7-L1 dermatome site, the block is considered successful and patients will be transferred to ESWL Room.
Active Comparator: Group E
(n=30) will receive unilateral erector spinae plane block
Procedure: Erector spinae plane block
Patients will be placed in the lateral decubitus position according to the selected site. After sterilization and draping of the skin, using US probe, the block will be applied in the plane deep to the erector spinae muscles and superficial to the transverse process. After 20 min, sensory blockade will be assessed with pinprick test, if loss of sensation is achieved at the T7-L1 dermatome site, the block is considered successful and patients is transferred to ESWL Room.
No Intervention: Group C
(n=30) will be control group receiving no intervention, managed only with conventional analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic Effect: cumulative opioid dose
Time Frame: 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)
At 30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone fragmentation: clearance rate
Time Frame: 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.
one week after ESWL session
Block failure rate
Time Frame: 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.
Immediately After 20 minutes of intervention
The regional block time
Time Frame: 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.
procedure (At the end of intervention)
Feasibility of visualisation
Time Frame: 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.
procedure (At the end of intervention)
Adverse effects
Time Frame: 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).
immediately after 20 minutes of intervention
Patient satisfaction
Time Frame: 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
At 30 minutes
Stone fragmentation: shockwave energy
Time Frame: 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
at 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Investigators

  • Principal Investigator: Mohamed G Ahmed, MD, Lecturer in anesthesiology intensive care and pain management, South Valley University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

May 28, 2023

First Submitted That Met QC Criteria

June 30, 2023

First Posted (Actual)

July 10, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 16, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Regional blocks in ESWL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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