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PainNCT05937256

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

A study testing Quadratus lumborum block type III and Erector spinae plane block in people with Pain and Lithiasis, run by South Valley University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Pain, Lithiasis
What is being tested?
Quadratus lumborum block type III and Erector spinae plane block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteEgypt
Study dates
1 Dec 2023to 1 Dec 2024
Phase
Interventional
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Known local anesthetic drug sensitivity.
  • Preexisting infection at block site
  • Coagulopathy or anticoagulation.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • South Valley University

    Qina, Qena Governorate, 83523

Other trials in Egypt

About this study

Official title: 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.

Read the 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.

Conditions
Pain, Lithiasis
Being tested
Quadratus lumborum block type III, Erector spinae plane block
Medical subject headings
Pain, Lithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quadratus lumborum block type IIIProcedure or surgery

    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.

  • Erector spinae plane blockProcedure or surgery

    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.

Study groups in NCT05937256
Study groupRoleWhat they receive
Group QActive comparator(n=30) will receive unilateral quadratus lumborum block type III
Receives: Procedure: Quadratus lumborum block type III
Group EActive comparator(n=30) will receive unilateral erector spinae plane block
Receives: Procedure: Erector spinae plane block
Group CNo intervention(n=30) will be control group receiving no intervention, managed only with conventional analgesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Analgesic Effect: cumulative opioid dose

    Comparing analgesic Effect of both QLB and ESPB by calculating the total opioid consumption over the total duration of session (approximately 30 minutes)

    Measured: At 30 minutes

Secondary outcomes (7)

  1. Stone fragmentation: clearance rate

    Determining if stone fragmentation considered satisfactory or not, by Follow up kidney, ureter and bladder x-ray (KUB) and Ultrasound.

    Measured: one week after ESWL session

  2. Stone fragmentation: shockwave energy

    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

    Measured: at 30 minutes

  3. Block failure rate

    the block will be considered a failed block if the sensory block level of T7-L1 is not achieved after assessment with pinprick test.

    Measured: Immediately After 20 minutes of intervention

  4. The regional block time

    defined as the time taken from the start of the ultrasound scan to the completion of the local anesthetic injection.

    Measured: procedure (At the end of intervention)

  5. Feasibility of visualisation

    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.

    Measured: procedure (At the end of intervention)

  6. Adverse effects

    The incidence of adverse effects local (anesthetic toxic reactions, bleeding, or hematoma at the puncture position; failure of block).

    Measured: immediately after 20 minutes of intervention

  7. Patient satisfaction

    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

    Measured: At 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2023
  2. Study start1 Dec 2023
  3. Primary completion1 Sep 2024
  4. Study completion1 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
controlled, randomized, assessor blinded clinical trial.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05937256
Sponsor's protocol ID
Regional blocks in ESWL
Status last verified
Mar 2025
First submitted
28 May 2023
Last updated
19 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yayik AM, Ahiskalioglu A, Alici HA, Celik EC, Cesur S, Ahiskalioglu EO, Demirdogen SO, Karaca O, Adanur S. Less painful ESWL with ultrasound-guided quadratus lumborum block: a prospective randomized controlled study. Scand J Urol. 2019 Dec;53(6):411-416. doi: 10.1080/21681805.2019.1658636. Epub 2019 Sep 9.

    PubMed 31496381

  • Yayik AM, Celik EC, Ahiskalioglu A. An unusual usage for ultrasound guided Quadratus Lumborum Block: Pediatric extracorporeal shock wave lithotripsy. J Clin Anesth. 2018 May;46:47-48. doi: 10.1016/j.jclinane.2018.01.016. Epub 2018 Mar 26. No abstract available.

    PubMed 29414615

  • Bovelander E, Weltings S, Rad M, van Kampen P, Pelger RCM, Roshani H. The Influence of Pain on the Outcome of Extracorporeal Shockwave Lithotripsy. Curr Urol. 2019 Mar 8;12(2):81-87. doi: 10.1159/000489424.

    PubMed 31114465

  • Oh SK, Lim BG, Won YJ, Lee DK, Kim SS. Analgesic efficacy of erector spinae plane block in lumbar spine surgery: A systematic review and meta-analysis. J Clin Anesth. 2022 Jun;78:110647. doi: 10.1016/j.jclinane.2022.110647. Epub 2022 Jan 11.

    PubMed 35030493

  • El-Boghdadly K, Desai N, Halpern S, Blake L, Odor PM, Bampoe S, Carvalho B, Sultan P. Quadratus lumborum block vs. transversus abdominis plane block for caesarean delivery: a systematic review and network meta-analysis. Anaesthesia. 2021 Mar;76(3):393-403. doi: 10.1111/anae.15160. Epub 2020 Jul 4.

    PubMed 32621529

Questions about this trial

What is this clinical trial studying?

A study testing Quadratus lumborum block type III and Erector spinae plane block in people with Pain and Lithiasis, run by South Valley University at 1 site in Egypt.

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 6 inclusion and 9 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: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Analgesic Effect: cumulative opioid dose (time frame: At 30 minutes). 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 NCT05937256, which also lists 5 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 19 Mar 2025.

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