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

Primary Purpose

Pain, Lithiasis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Quadratus lumborum block type III
Erector spinae plane block
Sponsored by
South Valley University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    No Intervention

    Arm Label

    Group Q

    Group E

    Group C

    Arm Description

    (n=30) will receive unilateral quadratus lumborum block type III

    (n=30) will receive unilateral erector spinae plane block

    (n=30) will be control group receiving no intervention, managed only with conventional analgesia

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    Stone fragmentation: clearance rate
    Determining if stone fragmentation considered satisfactory or not, by Follow up kidney, ureter and bladder x-ray (KUB) and Ultrasound.
    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
    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.
    The regional block time
    defined as the time taken from the start of the ultrasound scan to the completion of the local anesthetic injection.
    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.
    Adverse effects
    The incidence of adverse effects local (anesthetic toxic reactions, bleeding, or hematoma at the puncture position; failure of block).
    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

    Full Information

    First Posted
    May 28, 2023
    Last Updated
    July 8, 2023
    Sponsor
    South Valley University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05937256
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2024 (Anticipated)
    Study Completion Date
    March 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    South Valley University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Lithiasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    controlled, randomized, assessor blinded clinical trial.
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group Q
    Arm Type
    Active Comparator
    Arm Description
    (n=30) will receive unilateral quadratus lumborum block type III
    Arm Title
    Group E
    Arm Type
    Active Comparator
    Arm Description
    (n=30) will receive unilateral erector spinae plane block
    Arm Title
    Group C
    Arm Type
    No Intervention
    Arm Description
    (n=30) will be control group receiving no intervention, managed only with conventional analgesia
    Intervention Type
    Procedure
    Intervention Name(s)
    Quadratus lumborum block type III
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Erector spinae plane block
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Analgesic Effect: cumulative opioid dose
    Description
    Comparing analgesic Effect of both QLB and ESPB by calculating the total opioid consumption over the total duration of session (approximately 30 minutes)
    Time Frame
    At 30 minutes
    Secondary Outcome Measure Information:
    Title
    Stone fragmentation: clearance rate
    Description
    Determining if stone fragmentation considered satisfactory or not, by Follow up kidney, ureter and bladder x-ray (KUB) and Ultrasound.
    Time Frame
    one week after ESWL session
    Title
    Stone fragmentation: shockwave energy
    Description
    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
    Time Frame
    at 30 minutes
    Title
    Block failure rate
    Description
    the block will be considered a failed block if the sensory block level of T7-L1 is not achieved after assessment with pinprick test.
    Time Frame
    Immediately After 20 minutes of intervention
    Title
    The regional block time
    Description
    defined as the time taken from the start of the ultrasound scan to the completion of the local anesthetic injection.
    Time Frame
    procedure (At the end of intervention)
    Title
    Feasibility of visualisation
    Description
    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.
    Time Frame
    procedure (At the end of intervention)
    Title
    Adverse effects
    Description
    The incidence of adverse effects local (anesthetic toxic reactions, bleeding, or hematoma at the puncture position; failure of block).
    Time Frame
    immediately after 20 minutes of intervention
    Title
    Patient satisfaction
    Description
    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
    Time Frame
    At 30 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed G Ahmed
    Phone
    01003072269
    Ext
    +02
    Email
    zeinab5aton@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohamed G Ahmed, MD
    Organizational Affiliation
    Lecturer in anesthesiology intensive care and pain management, South Valley University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31496381
    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.
    Results Reference
    background
    PubMed Identifier
    29414615
    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.
    Results Reference
    background
    PubMed Identifier
    31114465
    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.
    Results Reference
    background
    PubMed Identifier
    35030493
    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.
    Results Reference
    background
    PubMed Identifier
    32621529
    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.
    Results Reference
    background

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

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