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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05937256
• Other study ID #: Regional blocks in ESWL
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2024
• Source: South Valley University
• Contact: Mohamed G Ahmed, MD
• Phone: 01003072269
• Email: zeinab5aton[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lithiasis
• Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	South Valley University	Qina	Qena

Sponsors (1)

Lead Sponsor	Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	At 30 minutes
Secondary	Stone fragmentation: clearance rate	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
Secondary	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	at 30 minutes
Secondary	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.	Immediately After 20 minutes of intervention
Secondary	The regional block time	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)
Secondary	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.	procedure (At the end of intervention)
Secondary	Adverse effects	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
Secondary	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	At 30 minutes