Clinical trial NCT05937256: Quadratus Lumborum Block Versus Erector Spinae Plane Block in Extracorporeal Shock Wave Lithotripsy(ESWL)
Official title: Quadratus Lumborum Block Versus Erector Spinae Plane Block As Analgesic Alternatives During Extracorporeal Shock Wave Lithotripsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lithiasis
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: controlled, randomized, assessor blinded clinical trial.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Analgesic Effect: cumulative opioid dose
timeFrame: At 30 minutes
Secondary outcomes:
measure: Stone fragmentation: clearance rate
timeFrame: one week after ESWL session
measure: Stone fragmentation: shockwave energy
timeFrame: at 30 minutes
measure: Block failure rate
timeFrame: Immediately After 20 minutes of intervention
measure: The regional block time
timeFrame: procedure (At the end of intervention)
measure: Feasibility of visualisation
timeFrame: procedure (At the end of intervention)
measure: Adverse effects
timeFrame: immediately after 20 minutes of intervention
measure: Patient satisfaction
timeFrame: At 30 minutes
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: South Valley University
state: Qena
Study officials:
affiliation: Lecturer in anesthesiology intensive care and pain management, South Valley University
name: Mohamed G Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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.